510(k) K150946 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
FLASH Ostial System OTW-6.0mm x 12mm x 80cm, FLASH Ostial System OTW-6.0mm x 12mm x 135cm, FLASH Ostial System OTW-7.0mm x 12mm x 80cm, FLASH Ostial System OTW-7.0mm x 12mm x 135cm
| Applicant | Ostial Corporation, Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 8, 2015 |
| Received | Apr 8, 2015 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K150946
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.