510(k) K080500 ยท DYB Introducer, Catheter
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Mar 13, 2008 |
| Received | Feb 25, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K080500
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.