510(k) K180921 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Sapphire II PRO Balloon Dilatation Catheter
| Applicant | Orbusneich Medical Trading, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Jun 28, 2018 |
| Received | Apr 9, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K180921
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.