510(k) K203043 ยท QJP Catheter, Percutaneous, Neurovasculature
Route 92 Medical 070 Access System
| Applicant | Route 92 Medical, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Nov 11, 2020 |
| Received | Oct 6, 2020 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K203043
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, 070 Access System, REF 1004, Rxonly , Sterile EO. 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.