510(k) K122379 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM
| Applicant | Ostial Corporation, Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 5, 2012 |
| Received | Aug 6, 2012 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K122379
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 14, 2021 | Ostial Corporation FLASH Ostial System, Dual Balloon Angioplasty Catheter, REF: OAB6014BA Terminated |
LIT | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.