510(k) K861984 ยท DYB Introducer, Catheter
UMI CATH-SEAL, 13+14F & TRANSSEPTAL CATHETER INTRO
| Applicant | Universal Medical Instrument Corp., Ballston Spa NY, US |
| Decision | Substantially Equivalent, Aug 5, 1986 |
| Received | May 22, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861984
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.