510(k) K991102 ยท DTL Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass
COPILOT BLEEDBACK CONTROL VALVE, MODEL 1003331
| Applicant | Guidant Corp., Temecula CA, US |
| Decision | Substantially Equivalent, Jun 9, 1999 |
| Received | Apr 1, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K991102
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 12, 2011 | Abbott Vascular Abbott Vascular COPILOT Kit, COPILOT Bleedback Control Valve
Part Number : 1003330. For use in cardiac diagnostic or therapeutic procedures. Terminated |
DTL | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.