Home › Device types › DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
FDA product code DTM · Class 2 · Cardiovascular
103
Registered devices
261
Adverse events
5
Recalls
96
510(k) clearances
Devices with this code
QUADROX-i — Maquet Cardiopulmonary AGQUADROX-i — Maquet Cardiopulmonary AGCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationIntersept® — MEDTRONIC, INC.Affinity® — MEDTRONIC, INC.QUADROX-i — Maquet Cardiopulmonary AGCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationQUADROX-i — Maquet Cardiopulmonary AGINSPIRE — SORIN GROUP ITALIA SRLAffinity® — MEDTRONIC, INC.INSPIRE — SORIN GROUP ITALIA SRLMICRO — SORIN GROUP ITALIA SRLCapiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationSACRED HEART AORTIC LINE, FL — NOVOSCI CORP.Pall LeukoGuard LGB — Global Life Sciences Solutions USA LLCKids — SORIN GROUP ITALIA SRLTHI PURGE LINE W/O VALVE, TX. — NOVOSCI CORP.MICRO — SORIN GROUP ITALIA SRLCAPIOX®ARTERIAL FILTER — TERUMO CORPORATIONAffinity® — MEDTRONIC, INC.PLEGIOX Cardioplegia Heat Exchanger — Maquet Cardiopulmonary AGLINE, ARTERIAL FILTER PURGE — NOVOSCI CORP.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2019-11-14 | Medtronic Perfusion Systems | Medtronic has identified an out of-specification condition exhibiting excess plastic (flash) in the arterial filter directly above the outlet port. |
| 2013-07-26 | Terumo Cardiovascular Systems Corporation | Medical device used in cardiovascular procedures is defective. |
| 2013-06-14 | Medtronic Inc. Cardiac Rhythm Disease Management | Medtronic is recalling 148 Affinity Pediatric Arterial Filters from 2 manufacturing lots because a limited quantity of filters may have a small breach in the fi |
| 2008-05-09 | Medtronic Perfusion Systems | Medtronic is recalling selected Carmeda-coated cardiopulmonary bypass (CPB) products (e.g., oxygenators, reservoirs, pumps, cannulae and tubing packs) that were |
| 2005-10-06 | Cobe Cardiovascular, Inc | One way valve in the heart lung pack assembly may be missing. |
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