510(k) K161361 ยท MCW Catheter, Peripheral, Atherectomy
HawkOne Directional Atherectomy System
| Applicant | Medtronic Vascular, Inc., Plymouth MN, US |
| Decision | Substantially Equivalent, Oct 14, 2016 |
| Received | May 16, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161361
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 19, 2022 | ev3 Inc. Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-M and H1-M-INT., Multi-vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire.
The HawkOne directional ath Terminated |
MCW | None listed |
| Jan 19, 2022 | ev3 Inc. Medtronic HawkOne Directional Atherectomy System, Catalog numbers H1-S and H1-S-INT, Small Vessel, 6F (2.2 mm) Recommended sheath, 0.014" (0.36 mm) Compatible guidewire.
The HawkOne directional ather Terminated |
MCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.