510(k) K220568 ยท MCW Catheter, Peripheral, Atherectomy
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series
| Applicant | Cardiovascualr Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Apr 27, 2022 |
| Received | Feb 28, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K220568
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.