510(k) K223530 ยท NRY Catheter, Thrombus Retriever
Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing Set
| Applicant | Route 92 Medical, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Apr 11, 2023 |
| Received | Nov 23, 2022 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K223530
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, Full Length 070 Reperfusion System, REF: 7001, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature. Open, Classified |
NRY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.