510(k) K050015 ยท DYB Introducer, Catheter
MODIFIED ACUMEN SHEATH, MODEL TTWO767
| Applicant | Acumen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Feb 3, 2005 |
| Received | Jan 4, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K050015
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.