510(k) K111284 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
FLASH-C PTCA BALLOON DILATION CATHETER - 5MM X 19MM X 135CM / 6MM X 19MM X 135CM
| Applicant | Ostial Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, Aug 17, 2011 |
| Received | May 6, 2011 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K111284
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.