510(k) K070396 ยท DYB Introducer, Catheter
MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-8-45, BLS-7-45, BLS-6-45
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, May 22, 2007 |
| Received | Feb 12, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K070396
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.