510(k) K153682 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Chocolate XD PTCA Balloon Catheter
| Applicant | Trireme Medical, LLC, Pleasonton CA, US |
| Decision | Substantially Equivalent, Jun 23, 2016 |
| Received | Dec 22, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K153682
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.