510(k) K863917 ยท DYB Introducer, Catheter
CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS.
| Applicant | Cardio-Vascular Innovations, Inc., Chantilly VA, US |
| Decision | Substantially Equivalent, Jan 6, 1987 |
| Received | Oct 8, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K863917
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.