510(k) K854261 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
ADVANCED CARDIOVASCULAR SYSTEMS HEMOSTATIC VALVES
| Applicant | Advanced Cardiovascular Systems, Inc., Mountain View CA, US |
| Decision | Substantially Equivalent, Dec 4, 1985 |
| Received | Oct 23, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K854261
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23242 Terminated |
DTL | None listed |
| Feb 1, 2007 | Abbott Vascular-Cardiac Therapies dba Guidant Corporation ACS DUOSTAT Rotating Hemostatic Valve, 0.096 inch, for use with a dilatation catheter - Reference Number 23244 Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.