510(k) K113775 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
FLASH-C PTCA BALLOON DILATATION CATHETER- 4.0MM X 14MM X 135CM -4.0MM X 19MM X 135CM- 4.5MM X 14MM X 135CM-4.5MM X 19MM
| Applicant | Ostial Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, Jun 29, 2012 |
| Received | Dec 22, 2011 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K113775
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.