510(k) K103534 ยท DQY Catheter, Percutaneous
GLIDERXTREME PTA BALLOON CATHETER (CB) (OVER THE WIRE) 0.014 / 0.018 GUIDE WIRE
| Applicant | Trireme Medical, Inc., Pleasonton CA, US |
| Decision | Substantially Equivalent, Jan 5, 2011 |
| Received | Dec 1, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103534
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.