510(k) K071427 ยท MCW Catheter, Peripheral, Atherectomy
DIAMONDBACK 360 DEGREE ORBITAL ATHERECTOMY SYSTEM FOR TREATMENT OF A-V SHUNT STENOSIS
| Applicant | Cardiovascular Systems, Inc., Saint Paul MN, US |
| Decision | Substantially Equivalent, Aug 30, 2007 |
| Received | May 23, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K071427
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 |
| Apr 17, 2009 | Cardiovascular Systems, Inc. Diamondback 360, CSI ViperWire Orbital Atherectomy Guide Wire, REF: GW14335FRM. Sterilized with Ethylene Oxide. Manufactured for Cardiovascular Systems, Inc., St. Paul, MN 55112, USA. The ViperWi Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.