510(k) K053400 ยท DYB Introducer, Catheter
ACUMEN SINGLE-LUMEN DELIVERY SHEATH
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Jun 19, 2006 |
| Received | Dec 6, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K053400
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.