510(k) K881197 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER
| Applicant | Schneider-Shilley (Usa), Minneapolis MN, US |
| Decision | Substantially Equivalent, May 16, 1988 |
| Received | Mar 21, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K881197
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.