510(k) K190431 ยท DQY Catheter, Percutaneous
Route 92 Medical Delivery Catheter
| Applicant | Route 92 Medical, Inc., San Mateo CA, US |
| Decision | Substantially Equivalent, Mar 21, 2019 |
| Received | Feb 22, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K190431
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 24, 2024 | ROUTE 92 MEDICAL INC Route 92 Medical, Tenzing 7 Delivery Catheter, REF 1005, Rx Only, Sterile EO. Used for introduction of interventional devices into the neurovasculature. Open, Classified |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.