510(k) K083855 ยท DYB Introducer, Catheter
MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
| Applicant | Acumen Medical, Inc., Sunnyvale CA, US |
| Decision | Substantially Equivalent, Feb 17, 2009 |
| Received | Dec 24, 2008 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K083855
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.