510(k) K190634 ยท MCW Catheter, Peripheral, Atherectomy
Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System
| Applicant | Cardiovascular Systems, Inc., St.Paul MN, US |
| Decision | Substantially Equivalent, Jul 2, 2019 |
| Received | Mar 12, 2019 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K190634
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 21, 2021 | Cardiovascular Systems Inc DIAMONDBACK 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.5MM SOLID, 145 CM, REF DBP-150SOLID145 Terminated |
MCW | None listed |
| Jul 21, 2021 | Cardiovascular Systems Inc STEALTH 360 GEN2 PERIPHERAL ORBITAL ATHERECTOMY SYSTEM, 1.25MM MICRO, 145 CM, REF PRD-SC30-MICRO Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.