510(k) K934624 ยท DYB Introducer, Catheter
ACS ROTATING HEMOSTATIC VALVE & ACS DUOSTAT ROTATING HEMOSTATIC VALVE
| Applicant | Advanced Cardiovascular Systems, Inc., Santa Clara CA, US |
| Decision | Substantially Equivalent, Apr 13, 1994 |
| Received | Sep 27, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K934624
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS Rotating Hemostatic Valve, .115 inch, for use with a dilatation catheter - Reference Number 23245 Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.