510(k) K192344 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
Sapphire NC Plus Coronary Dilatation Catheter
| Applicant | Orbusneich Medical Trading, Inc., Fort Lauderdale FL, US |
| Decision | Substantially Equivalent, Sep 19, 2019 |
| Received | Aug 29, 2019 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K192344
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.