510(k) K243601 ยท NRY Catheter, Thrombus Retriever
Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing Set
| Applicant | Route 92 Medical, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, May 19, 2025 |
| Received | Nov 21, 2024 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K243601
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.