510(k) K133399 ยท MCW Catheter, Peripheral, Atherectomy
DIAMONDBACK 360 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM
| Applicant | Cardiovascular Systems Incorporated, Saint Paul MN, US |
| Decision | Substantially Equivalent, Nov 22, 2013 |
| Received | Nov 6, 2013 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K133399
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2014 | Cardiovascular Systems, Inc. CSI Cardiovascular Systems, Inc., Diamondback 360 Peripheral Orbital Atherectomy System, Model Number DBP-125MICRO145, Part Number 7-10003.
The Diamondback 360 Peripheral Orbital Atherectomy System i Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.