510(k) K152485 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm
| Applicant | Ostial Corporation, Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 16, 2016 |
| Received | Aug 31, 2015 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K152485
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.