510(k) K070197 ยท DYB Introducer, Catheter
ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODELS LDS-10-64-STY AND LDS-10-57-STY
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 23, 2007 |
| Received | Jan 22, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070197
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.