Is this your brand? Sign in to claim ownership.

Cardiovascular Systems, Inc.

Last updated May 24, 2026

What Cardiovascular Systems, Inc. makes

Cardiovascular Systems, Inc. manufactures mechanical atherectomy catheters designed for peripheral and coronary arteries, including line-powered systems for plaque removal. Their portfolio also includes guidewires for cardiac and peripheral vascular procedures, single-use vascular guide-catheters, and embolic protection filtering guidewires. Additionally, they produce saline/lubricant pumps for atherectomy systems and X-ray film rulers for procedural guidance.

The company’s devices are regulated under FDA pathways, including 510(k) clearances, PMA approvals, and UDI compliance, spanning Class I, Class II, and Class III classifications. Products are listed in the FDA’s regulatory databases, and the manufacturer operates from the United States.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Information

Country: US
Address: —
Website: csi360.com
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: 877-274-0360
PRRC Contact: —
EUDAMED SRN: —
FDA FEI Number: —
DUNS Number: 024954518

Catalogue (299)

Page 5 of 6

Device	Model / Reference	Registries	Class	Status
Diamondback 360 Peripheral Orbital Atherectomy System	K133999	FDA 510(k)	Class II	Active
Acs Deflectable Tip Guide Wire W/Microglide(r)coat	K882321	FDA 510(k)	Class II	Active
Acs Vsw Guide Wire	K913178	FDA 510(k)	Class II	Active
Balloon Dilation Catheter	K843501	FDA 510(k)	Class II	Active
Indeflator	K822245	FDA 510(k)	Class II	Active
Acs Wire Shaper	K862567	FDA 510(k)	Class II	Active
Indeflator Plus 30/Plus 30 Priority Pack9with The.096 Or.115 Rotating Hemostatic Valve)	K962495	FDA 510(k)	Class II	Active
Acs Hi-Torque Flex-T Guide Wire	K862360	FDA 510(k)	Class II	Active
Acs Soft-Tip Coronary Infusion Cath W/Side Holes	K883564	FDA 510(k)	Class II	Active
ViperCath XC Peripheral Exchange Catheter	K183000	FDA 510(k)	Class II	Active
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System	K190634	FDA 510(k)	Class II	Active
Acs Hi-Torque Floppy/Floppy Ii/Inter./Standard Gw	K881897	FDA 510(k)	Class II	Active
Cbis Catheter Pull-Back Device	K921879	FDA 510(k)	Class II	Active
Acs Hi-Torque Standard & Intermedi. Guide Wire	K881787	FDA 510(k)	Class II	Active
Adv Cardio Sys Dbl Lumen Balloon Dilata Catheter	K844972	FDA 510(k)	Class II	Active
Wholey Hi-Torque Guide Wires	K852354	FDA 510(k)	Class II	Active
Acs Indeflator P/T 20	K883452	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter For Intraluminal	K921631	FDA 510(k)	Class II	Active
Acs Hi-Torque Iron Man Guide Wire	K963702	FDA 510(k)	Class II	Active
Acs 0.015 & 0.018 Pressure Guide Wire W/Micro.	K882507	FDA 510(k)	Class II	Active
Low Profile Steerable-Intraoperative	K833248	FDA 510(k)	Class II	Active
Advanced Cardiovascular Systems Hemostatic Valves	K854261	FDA 510(k)	Class II	Active
Automatic Pull Back Device	K933517	FDA 510(k)	Class II	Active
Acs Rx Support Catheter	K911957	FDA 510(k)	Class II	Active
Acs Indeflator (modification)	K854310	FDA 510(k)	Class II	Active
Right Coronary Guiding Catheter	K833801	FDA 510(k)	Class II	Active
Acs Hi-Torque Floppy Guide Wire, 0.018 Inch	K864585	FDA 510(k)	Class II	Active
Acs Angioscope Guide Wire	K883000	FDA 510(k)	Class II	Active
010 Hi-Tor Inter/Stand Guidwire Preshape Tip/Modif	K914828	FDA 510(k)	Class II	Active
Low Profile Steerable Balloon Dilation	K843880	FDA 510(k)	Class II	Active
Et Hi-Flow Soft Tip/Et Hi-Flow/Enhanced Torque St	K882803	FDA 510(k)	Class II	Active
Cvis Insight Imaging Guide Catheter	K930232	FDA 510(k)	Class II	Active
Acs Et Hi-Flow/Enhanced Torque Coronary Guid Cath	K926421	FDA 510(k)	Class II	Active
Acs 0.025-In Hi-Torq Modif J/Stand Telesc Guidewir	K874776	FDA 510(k)	Class II	Active
Advanced Cardiovascular Systems Double Lumen Ballo	K853746	FDA 510(k)	Class II	Active
Acs Powerbase(tm) Coronary Guiding Catheter	K940559	FDA 510(k)	Class II	Active
Acs Urethan Coronary Guiding Catheter	K904884	FDA 510(k)	Class II	Active
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD	K151260	FDA 510(k)	Class II	Active
Acs Powerguide Coronary Guiding Catheter	K934009	FDA 510(k)	Class II	Active
ViperWire Advance Guide Wire, Stealth 360 Orbital Peripheral Atherectomy Device (PAD), DIAMONDBACK 360 Peripheral Atherectomy System	K180416	FDA 510(k)	Class II	Active
Diamondback 360* Orbital Atherectomy System, Stealth 360* Orbital Pad System	K111388	FDA 510(k)	Class II	Active
ViperCross Support Catheters	K211240	FDA 510(k)	Class II	Active
Indeflator 20/30 Inflation Device And 20/30 Priority Pack (with The .096 Or .115 Rotating Hemostatic Valve)	K961471	FDA 510(k)	Class II	Active
Acs Hi-Torque Balance(tm) Guide Wire	K925381	FDA 510(k)	Class II	Active
Acs Guide Wires With Modified Package Insert	K946029	FDA 510(k)	Class II	Active
Doc-Tite(tm) Guide Wire Extension	K931171	FDA 510(k)	Class II	Active
Diamondback 360 Degree Orbital Atherectomy System	K071350	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter	K904618	FDA 510(k)	Class II	Active
Acs Enhanced-Torque Coronary Guiding Catheter	K871425	FDA 510(k)	Class II	Active
Advanced Cardiovascular Balloon Dilata	K842556	FDA 510(k)	Class II	Active

Related Companies

Authorised Representatives

No authorised representatives on record.

Importers

Not available yet.

Notified Bodies

Not available yet.

Authorities

Not available yet.

FDA Recalls (17)

Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.

Cardiovascular Systems, Inc. has 17 recall records initiated between March 16, 2009, and November 22, 2021, all of which are marked as terminated. The recalls involve various medical devices, including atherectomy systems, guidewires, saline infusion pumps, and labeling corrections, with reasons ranging from potential structural failures (e.g., detachment risks, sheath cracking) and incorrect component inclusion to mislabeling issues (e.g., swapped lot labels, incorrect gauge specifications, and missing or inaccurate shelf-life dates).

AI-generated summary of the recall records listed below. It describes what the records state and is not an assessment of this manufacturer.

Date	Recall No.	Class	Status	Reason
Nov 22, 2021	Z-0394-2022	—	terminated	Under certain circumstances, the WIRION filter assembly may become difficult to withdraw. Under such circumstances, alternative means may be necessary for withdrawal and the device may be prone to tearing or separating which may result in a risk for embolization.
Jul 21, 2021	Z-2386-2021	—	terminated	There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Jul 21, 2021	Z-2385-2021	—	terminated	There is a potential mislabeling of the OAD crown sizes: 1.50mm Sold Crown OADs may be packaged s 1.25mm Micro Crown OADs and vice versa.
Apr 13, 2018	Z-3021-2018	—	terminated	The pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment.
Sep 14, 2017	Z-0505-2018	—	terminated	Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
Sep 14, 2017	Z-0506-2018	—	terminated	Cardiovascular Systems, Inc. (CSI) is removing the products because it was identified that the labeling for two lots of product s were potentially inadvertently switched during production.
Apr 14, 2017	Z-2122-2017	—	terminated	Cardiovascular Systems, Inc. (CSI). has initiated a recall to remove 1,396 7-10014 Saline Infusion Pumps (SIP) which were distributed by CSI between 07 April 2015 and 04 April 2017. The 7-10014 pumps may switch to stand-by during use requiring the pump to be reset prior to continuing treatment. To date, none of the associated complaints have resulted in any patient harm.
Mar 3, 2017	Z-1771-2017	—	terminated	Cardiovascular Systems, Inc. is recalling one lot of ViperWire Advance with Flextip, model VPR-GW-FT18 because it may contain a 0.014" ViperWire Advance Flextip product instead of the 0.018" ViperWire Advance with Flextip.
Feb 9, 2017	Z-1877-2017	—	terminated	CSI is recalling three lots of VIPERWIRE ADVANCE WITH FLEXTIP PERIPHERAL ATHERECTOMY GUIDEWIRE . It was discovered that 0.018in ViperWire Advance with Flextip product was packaged as a 0.014in ViperWire Advance with Flextip.
Dec 7, 2016	Z-1230-2017	—	terminated	CSI discovered that a 1.50mm Solid Crown OAD was labeled as a 1.50mm Crown OED.
Jun 13, 2016	Z-2051-2016	—	terminated	The pouch label was missing the use by date (UBD) of 2018-04.
Mar 4, 2015	Z-1290-2015	—	terminated	The OAD saline sheath outer layer may flake off from the catheter due to friction between the outer material layer and corresponding materials it may come in contact with during clinical use. If the material is large enough, it has the potential to cause a flow limiting embolism.
May 23, 2014	Z-2155-2014	—	terminated	CSI has initiated a recall on the Diamondback 360 Peripheral Orbital Atherectomy Device because it may contain a saline sheath that may experience cracking, fracture, and release particulate during use.
Jan 27, 2014	Z-1095-2014	—	terminated	Cardio vascular Systems Inc. has initiated a recall to request the immediate removal and return of Diamondback 360 Coronary Orbital Atherectomy Device (OAD). The device mistakenly contains a saline line that is used in our peripheral atherectomy device. This saline line was not part of the FDA approval for use in the coronary device. It therefore does not meet specification for this device. C
Jun 18, 2012	Z-1959-2012	—	terminated	CSI has initiated a recall on specific lot numbers of Stealth 360-degree Orbital Atherectomy devices which have the potential for an insufficient crown solder bond that may result in the crown becoming detached from the driveshaft.
Apr 16, 2009	Z-2028-2009	—	terminated	CSI is correcting (8) packages of Diamondback 360 due to a missing "Use By Date" on the device labeling. The labelling should have been a 12 month shelf life (2010-02) rather than no information for shelf life. The units affected by this correction are sterilized products, and CSI believes that there is no immediate risk to health associated with these distributed products recognizing the valid s
Mar 16, 2009	Z-1250-2009	—	terminated	CSI is recalling 10 devices due to a mislabeling of the shelf life as shown on the device labeling. The labeling shown on the affected devices represents a 24 month shelf life rather than a 6 month shelf life that should have been indicated.