510(k) K111544 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
GLIDER PTCA BALLOON CATHETER
| Applicant | Trireme Medical, Inc., Pleasanton CA, US |
| Decision | Substantially Equivalent, Mar 2, 2012 |
| Received | Jun 3, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111544
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.