510(k) K222743 ยท QJP Catheter, Percutaneous, Neurovasculature
Route 92 Medical Full Length 070 Access System
| Applicant | Route 92 Medical, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Oct 4, 2022 |
| Received | Sep 9, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K222743
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical Full Length 070 Access System, REF 7002, Rxonly, SterileEO. Used for Introduction of interventional devices into the neurovasculature. Open, Classified |
QJP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.