510(k) K122178 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH-C PTCA BALLOON DILATATION CATHETER - 4MM X 19MM X 1
| Applicant | Ostial Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, Oct 11, 2012 |
| Received | Jul 23, 2012 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K122178
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.