510(k) K092455 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
MODIFICATION TO: POLARCATH PERIPHERAL DILATATION SYSTEM
| Applicant | Boston Scientific Corporation, Maple Grove MN, US |
| Decision | Substantially Equivalent, Sep 4, 2009 |
| Received | Aug 10, 2009 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K092455
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.