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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 6 of 6

Device	Model / Reference	Registries	Class	Status
Acs .010 Hi-Torque Inter. And Standard Guide Wire	K902207	FDA 510(k)	Class II	Active
Acs Angiotrak(tm) System	K921719	FDA 510(k)	Class II	Active
Cvis Ultra-Scan One Imaging System	K891386	FDA 510(k)	Class II	Active
Advanced Cardiovascular Sys Low Profile Pta Balloo	K851854	FDA 510(k)	Class II	Active
Microview Ii/Microrail Ii Catheters	K942231	FDA 510(k)	Class II	Active
Coronary Guiding Catheter	K830829	FDA 510(k)	Class II	Active
Acs Hi-Torque Extra S'port Guide Wire	K942066	FDA 510(k)	Class II	Active
Diamondback 360 Peripheral Orbital Atherectomy System	K152694	FDA 510(k)	Class II	Active
Acs Wholey Hi-Torque Guide Wire	K861765	FDA 510(k)	Class II	Active
Acs Angioscopic Catheter	K905715	FDA 510(k)	Class II	Active
.010 Hi-Torque Guide Wires With Preshaped Tip	K911460	FDA 510(k)	Class II	Active
Intraoperative Balloon Dilation Cath.	K822393	FDA 510(k)	Class II	Active
Advanced Cardiovascular-Coronary Guid	K842195	FDA 510(k)	Class II	Active
Acs Sof-T Guide Wiree	K840795	FDA 510(k)	Class II	Active
Acs 0.010 Hi-Torque Floppy Gold Guide Wire	K884895	FDA 510(k)	Class II	Active
Coronary Guiding Catheter-Modified	K831563	FDA 510(k)	Class II	Active
.010 Hi-Torque Plus(tm) Guide Wire	K913328	FDA 510(k)	Class II	Active
Acs Schwarten Xt Balloon Dilatation Catheter	K882925	FDA 510(k)	Class II	Active
.10' Hi-Torque Floppy, Inter. & Stand. Guide Wire	K915723	FDA 510(k)	Class II	Active
Acs Indeflator Plus (modification #2)	K872981	FDA 510(k)	Class II	Active
Selective Infusion Ii Catheter	K914751	FDA 510(k)	Class II	Active
Diamondback 360 Peripheral Orbital Atherectomy System	K170792	FDA 510(k)	Class II	Active
Acs Coronary Guiding Catheter	K861236	FDA 510(k)	Class II	Active
Diamonback 360 Peripheral Orbital Atherectomy System, Diamondback 360 Stealth Orbital Atherectomy system	K210586	FDA 510(k)	Class II	Active
DIAMONDBACK 360 Peripheral Orbital Atherectomy System, DIAMONDBACK 360 Peripheral Orbital Atherectomy System, Exchangeable Series, Stealth 360 Peripheral Orbital Atherectomy System	K220109	FDA 510(k)	Class II	Active
Vipersphere Pta Balloon Catheter	K083139	FDA 510(k)	Class II	Active
Acs.018 Hi-Torque Floppy Guide Wire - Acs Hi-Torque Floppy Extra Support Guide Wire	K934602	FDA 510(k)	Class II	Active
Tad Intermediate & Tad Standard Guide Wire	K882928	FDA 510(k)	Class II	Active
Modifications To Acs Coronary Guiding Catheter W/T	K851574	FDA 510(k)	Class II	Active
Acs Hi-Torque Tapered Diameter Guide Wire	K861574	FDA 510(k)	Class II	Active
Diamondback 360 Dbx	K090521	FDA 510(k)	Class II	Active
Bsc, Sonicath Ultra Imaging Catheter 3.2f/20mhz(37410/456221 & Bsc, Sonicath Ultra Imaging Catheter 2.9f/20mhz/37411/	K970049	FDA 510(k)	Class II	Active
Cvis Insight Iii System	K921750	FDA 510(k)	Class II	Active
Loc Guide Wire Extension	K934339	FDA 510(k)	Class II	Active
Rx Herculink 14 Biliary Stent System, Model 1005126-18, 1005128-18, 1005130-18, 1005132-18, 1005134-18, 1005136-18, 1005138-18	K990867	FDA 510(k)	Class II	Active
Diamondback 360 Degree Orbital Atherectomy System	K072800	FDA 510(k)	Class II	Active
Acs Rotating Hemo Valve - Dual Access Type	K861847	FDA 510(k)	Class II	Active
Introducer Set	K821188	FDA 510(k)	Class II	Active
Acs Funnel Introducer	K875158	FDA 510(k)	Class II	Active
Cvis Ultra-Scan One Imaging Catheter	K893837	FDA 510(k)	Class II	Active
Acs Hi-Torque Coronary Guiding Catheter W/Soft Tip	K874874	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter For Intraluminal Use	K921147	FDA 510(k)	Class II	Active
Acs Gold Series Elastinite Guide Wire	K896379	FDA 510(k)	Class II	Active
.014 Hi-Torque Floppy Pathfinder Guide Wire	K913631	FDA 510(k)	Class II	Active
Acs Hi-Torque Tapered Diameter Guide Wires	K854830	FDA 510(k)	Class II	Active
Ptca Balloon Catheters & Access.	K834433	FDA 510(k)	N/A	Active
Acs Hi-Torque Extra S'port(tm) Guide Wire	K950156	FDA 510(k)	Class II	Active
Acs Rx Gemini Coronary Dilatation Catheter	P810046	FDA PMA	Class II	Active
Diamondback 360 Coronary Orbital Atherectomy Device (oad), Orbital Atherectomy System Pump (oas Pump), Viperwire Advance	P130005	FDA PMA	Class III	Active

Related Companies

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Authorities

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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.