510(k) K183043 · NRY Catheter, Thrombus Retriever
0.071 ID MantaRay Reperfusion Catheter, 0.055 ID MantaRay Reperfusion Catheter, 0.045 ID MantaRay Reperfusion Catheter, 0.035 ID MantaRay Reperfusion Catheter
| Applicant | Imperative Care, Inc., Campbell CA, US |
| Decision | Substantially Equivalent, Apr 17, 2019 |
| Received | Nov 2, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K183043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 29, 2021 | IMPERATIVE CARE INC Imperative Care, ZOOM 71 Reperfusion Catheter, REF: ICRC071137, TRX Tip, 137 cm, 6F (.083 in/2.11 mm), .071 in/1.8 mm), STERILE.EO, Rx Only, UDI: (01) 00812212030191. For neurovascular procedures. Completed |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.