510(k) K151260 ยท MCW Catheter, Peripheral, Atherectomy
ViperWire Advance Guide Wire, Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Orbital PAD
| Applicant | Cardiovascular System, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Jun 10, 2015 |
| Received | May 12, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K151260
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2017 | Cardiovascular Systems Inc ViperWire Advance with Flextip Peripheral Atherectomy Guide Wire, Part Number: 7-10026-01,Model Number: VPR-GW-FT14.
Product Usage:
The Stealth 360 Orbital PAD System and the Diamondback 360 Periphe Terminated |
MCW | None listed |
| Mar 3, 2017 | Cardiovascular Systems Inc ViperWire Advance Peripheral Guide Wire with Flex Tip, Model No. VPR-GW-FT18. Sterilized with Ethylene Oxide.
The guide wire is a smooth, stainless steel wire, with a silicone coating, and a radio Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.