510(k) K034025 ยท DYB Introducer, Catheter
NMT MEDICAL TRANSSEPTAL SHEATH SET, MODELS TSS-10-HSC, TSS-11-HSC, TSS12-HSC
| Applicant | Nmt Medical, Inc., Boston MA, US |
| Decision | Substantially Equivalent, Mar 26, 2004 |
| Received | Dec 29, 2003 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K034025
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.