510(k) K880194 ยท LIT Catheter, Angioplasty, Peripheral, Transluminal
KENSEY CATHETER
| Applicant | Theratek, Inc., Miami FL, US |
| Decision | Substantially Equivalent, Apr 18, 1988 |
| Received | Jan 19, 1988 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K880194
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.