510(k) K112281 ยท DQY Catheter, Percutaneous
GLIDERXTREME PTA BALLON CATHETER (OVER THE WIRE) 0.018 GUIDE WIRE 6100-XXXXX, 6100CB-XXXX
| Applicant | Trireme Medical, Inc., Pleasonton CA, US |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | Aug 9, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K112281
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.