510(k) K212027 ยท MCW Catheter, Peripheral, Atherectomy
TurboHawk Plus Directional Atherectomy System
| Applicant | Medtronic, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Aug 24, 2021 |
| Received | Jun 29, 2021 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K212027
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 7, 2022 | ev3 Inc. Medtronic TurboHawk Plus Directional Atherectomy System 6F, Multi-vessel, Catalog number THP-M. For use in peripheral vasculature. Terminated |
MCW | None listed |
| Mar 7, 2022 | ev3 Inc. Medtronic TurboHawk Plus Directional Atherectomy System 6F, Small Vessel, Catalog number THP-S. For use in peripheral vasculature. Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.