510(k) K103657 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
SAPPHIRE
| Applicant | Orbusneich Medical, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Aug 9, 2011 |
| Received | Dec 15, 2010 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K103657
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.