510(k) K122581 ยท DQY Catheter, Percutaneous
MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
| Applicant | Concentric Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Nov 21, 2012 |
| Received | Aug 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122581
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 8, 2013 | Concentric Medical Inc FlowGate Balloon Guide Catheter;
Manufactured by Concentric Medical, Mountain View, CA.
FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinfor Terminated |
DQY | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.