510(k) K090521 ยท MCW Catheter, Peripheral, Atherectomy
DIAMONDBACK 360 DBX
| Applicant | Cardiovascular Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Mar 20, 2009 |
| Received | Feb 26, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K090521
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jun 13, 2016 | Cardiovascular Systems Inc ViperWire Advance Peripheral Guide Wire, Sterilized with Ethylene Oxide, Rx Only. Part number 72023-02, Model Number VPR-GW-17. Five (5) guide wire pouches in one (1) guide wire box. For use with CSI Terminated |
MCW | None listed |
| Sep 10, 2009 | Cardiovascular Systems, Inc. Diamondback 360 Orbital Atherectomy Device, 1.50 LT Classic, Model #DB-150L, CSI Part # 70025-02
Expiration 2012-02, Sterilized with Ethylene Oxide , Cardiovascular Systems, Inc., St. Paul, MN USA.
Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.