510(k) Report

FDA applicant

Cardiovascular System, Inc.

Saint Paul, MN1 decision2015–20152 recalls

FDA records 1 decision for Cardiovascular System, Inc. (Saint Paul, MN) in 2015: 1 510(k) clearance. All are in product code MCW (Catheter, Peripheral, Atherectomy). Its devices cite 5 predicates, 0 of them its own earlier devices. 2 recalls are linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Cardiovascular System, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

2in 2017

2017: 2
2015high 2 (2017) · low 0 (2015)2026

Class I Class II/III not classified

FIG. 1 — Cardiovascular System, Inc. by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Cardiovascular System, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • MCWCatheter, Peripheral, Atherectomy1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 1 time; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADCardiovascular System, Inc. · 20151cites it

What has FDA decided for it lately?

  • K151260ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PADCardiovascular System, Inc. · 20152 recalls

The one decision as Cardiovascular System, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K151260ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized…Mar 3, 2017Class II
  • K151260ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number…Feb 9, 2017Class II

Other applicant names beginning “Cardiovascular”

FDA records each applicant name separately; these may or may not be the same firm.

Cardiovascular Systems, Inc. 29Cardiovascular Imaging Systems, Inc. 19Cardiovascular Diagnostics, Inc. 13Cardiovascular Dynamics, Inc. 11Cardiovascular Devices, Inc. 8Cardiovascular Diagnostic Services 8Cardiovascular Imaging Technologies 7Cardiovascular Research, Inc. 2Cardiovascular Imaging Solutions, Ltd. 1Cardiovascular Group, Inc. 1Cardiovascular Innovations 1