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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)

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Device	Model / Reference	Registries	Class	Status
Diamondback 360 Degree Orbital Atherectomy System With Viperslide Lubricant	K082981	FDA 510(k)	Class II	Active
Acs Powerbase Guilding Catheter	K952205	FDA 510(k)	Class II	Active
Low Profile Steerable Balloon Dilata	K831403	FDA 510(k)	Class II	Active
Coronary Infusion Catheter W/Sideholes	K850353	FDA 510(k)	Class II	Active
Cvis Insight 15mhz Catheters For Peripheral Use	K901691	FDA 510(k)	Class II	Active
Guide Wire	K821190	FDA 510(k)	Class II	Active
Acs Anchor Exchange Device	K955175	FDA 510(k)	Class II	Active
Acs Hi-Torque Cross-It 400xt Guide Wire	K992169	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter	K924922	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter	K905625	FDA 510(k)	Class II	Active
Diamondback 360 Degree Orbital Atherectomy System For Treatment Of A-V Shunt Stenosis	K071427	FDA 510(k)	Class II	Active
Diamondback 360 Peripheral Orbital Atherectomy System	K150732	FDA 510(k)	Class II	Active
Acs Hi-Torque Guide Wires	K874202	FDA 510(k)	Class II	Active
Acs Brachial Coronary Guiding Cath W/Tapered Tip	K860580	FDA 510(k)	Class II	Active
.018 Hi-Torque Floppy Guide Wire W/ Preshaped Tip	K902755	FDA 510(k)	Class II	Active
Acs(r) Hi-Torque Gold(tm) Guide Wire	K884262	FDA 510(k)	Class II	Active
Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series	K182397	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter	K897153	FDA 510(k)	Class II	Active
Acs Hi-Torque Flex-T Guide Wire (modification)	K872220	FDA 510(k)	Class II	Active
WIRION Embolic Protection System	K210282	FDA 510(k)	Class II	Active
Hi-Torque Middle Support .012 Guide Wire With Hydrocoat Hydrophilic Coating	K012534	FDA 510(k)	Class II	Active
Stealth 360 Orbital Pad System	K110389	FDA 510(k)	Class II	Active
Vascular Guide Wire	K913353	FDA 510(k)	Class II	Active
Modification To Acs Coronary Guiding	K841992	FDA 510(k)	Class II	Active
Snap-On Torquer	K862409	FDA 510(k)	Class II	Active
Brachial Coronary Guiding Catheter	K822862	FDA 510(k)	Class II	Active
Acs Soft-Tip Coronary Infusion Catheter W/Sidehole	K875269	FDA 510(k)	Class II	Active
Wirion	K200198	FDA 510(k)	Class II	Active
Ptca Balloon Catheters & Accessories	K843944	FDA 510(k)	Class II	Active
Otw Megalink Sds Biliary Stent System	K000550	FDA 510(k)	Class II	Active
Cvis Longview	K930311	FDA 510(k)	Class II	Active
Stealth 360 Orbital Pad System	K122987	FDA 510(k)	Class II	Active
Cvis Insight Catheters For Intracardiac Use	K921148	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheter	K901562	FDA 510(k)	Class II	Active
Modification To: Diamondback 360 Orbital Atherectomy System	K072748	FDA 510(k)	Class II	Active
ViperCross Support Catheters	K212725	FDA 510(k)	Class II	Active
.010 Hi-Torque Floppy Guide Wire W/Preshaped Tip	K905502	FDA 510(k)	Class II	Active
Acs Advanced Concept Guide Wire	K900386	FDA 510(k)	Class II	Active
Acs Torque Device, Acs Guide Wire Introducer, Acs Guide Wire Accessory Kits	K950752	FDA 510(k)	Class II	Active
Acs Tourgide Guiding Catheter	K953987	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	K203008	FDA 510(k)	Class II	Active
Acs Indeflator Xx	K896849	FDA 510(k)	Class II	Active
Veripath Peripheral Guiding Catheter	K994229	FDA 510(k)	Class II	Active
Wholey Hi-Torque Guide Wires	K852123	FDA 510(k)	Class II	Active
ViperCath XC Peripheral Exchange Catheter	K211251	FDA 510(k)	Class II	Active
Coronary Infusion Catheter	K831717	FDA 510(k)	Class II	Active
Acs Selective Infusion Catheter	K885237	FDA 510(k)	Class II	Active
Acs Rotating Hemostatic Valve & Acs Duostat Rotating Hemostatic Valve	K934624	FDA 510(k)	Class II	Active
Cvis Insight Imaging Catheters	K911414	FDA 510(k)	Class II	Active
Advanced Cardiovascular Systems Angioject	K844045	FDA 510(k)	Class II	Active

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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.