510(k) K071253 ยท DTM Filter, Blood, Cardiopulmonary Bypass, Arterial Line
AFFINITY PEDIATRIC ARTERIAL FILTER, MODEL S4014 AND WITH CARMEDA BIOACTIVE SURFACE, MODEL CB4014
| Applicant | Medtronic Vascular, Minneapolis MN, US |
| Decision | Substantially Equivalent, Jul 3, 2007 |
| Received | May 4, 2007 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K071253
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 14, 2013 | Medtronic Inc. Cardiac Rhythm Disease Management Medtronic Affinity Pediatric Arterial Filter, model number S4014, sterilized using ethylene oxide.
Recall Update 9/6/13: Medtronic, Red cross Infant Pack 1/B, South-Africa, REF M272403C, Sterile E Terminated |
DTM | None listed |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014 Terminated |
DTM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.