510(k) K062145 ยท DYB Introducer, Catheter
MODIFIED ACUMEN LEAD DELIVERY SHEATH, MODELS LDS-10-57, LDS-10-57-90, LDS-10-64 AND LDS-10-64-90
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Aug 23, 2006 |
| Received | Jul 27, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K062145
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.