Panels › Cardiovascular › Product code DTM · Class 2
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
Regulation 870.4260
1510(k)s in 12 months (96 all time)
0recalls in 12 months (5 all time)
3recalls that name a 510(k)
Top companies in DTM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 14, 2019 | Medtronic Perfusion Systems Medtronic Affinity, 38um Arterial Filter, Catalog number REF 351 Terminated |
DTM | K952532 |
| Sep 20, 2013 | Terumo Cardiovascular Systems Corporation Terumo Pall AL6X Arterial Blood Line Filter, labeled in part Terumo Cardiovascular Systems Corporation, packaged as part of a Terumo Cardiovascular Procedure Kit or as a single, sterile filter unit
S Terminated |
DTM | None listed |
| 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 | K071253 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Affinity Pediatric arterial Filter, Arterial Line Filter for Cardiopulmonary Bypass. Catalog Number: CB4014 Terminated |
DTM | K071253 |
| Dec 2, 2005 | Cobe Cardiovascular, Inc Custom heart lung perfusion packs Terminated |
DTM | None listed |
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