510(k) K051515 ยท DYB Introducer, Catheter
MODIFIED ACUMEN SHEATH, MODEL TTW 10-65
| Applicant | Acumen Medical, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Sep 1, 2005 |
| Received | Jun 8, 2005 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K051515
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.