510(k) K122070 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.014 GUIDE WIRE, CHOCOLATE PTA BALLOON CATHETER (OVER THE WIRE) 0.18 G
| Applicant | Trireme Medical, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Aug 15, 2012 |
| Received | Jul 16, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122070
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.