510(k) K861847 ยท LOX Catheters, Transluminal Coronary Angioplasty, Percutaneous
ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
| Applicant | Advanced Cardiovascular Systems, Inc., Temecula CA, US |
| Decision | Substantially Equivalent, Jun 16, 1986 |
| Received | May 13, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K861847
| 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.