510(k) K052555 ยท DTQ Console, Heart-Lung Machine, Cardiopulmonary Bypass
MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB
| Applicant | Rand S.R.L., Minneapolis MN, US |
| Decision | Substantially Equivalent, Mar 15, 2006 |
| Received | Sep 16, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052555
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2007 | Medtronic Perfusion Systems Medtronic Performer CPB-Universal R2100375.
Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures. Terminated |
DTQ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.