Home › Device types › DTM
Filter, Blood, Cardiopulmonary Bypass, Arterial Line
FDA product code DTM · Class 2 · Cardiovascular
100
Registered devices
261
Adverse events
5
Recalls
96
510(k) clearances
Devices with this code
TRILLIUM® AFFINITY® — MEDTRONIC, INC.SACRED HEART AORTIC LINE, FL — NOVOSCI CORP.Affinity™ — MEDTRONIC, INC.LINE, ARTERIAL FILTER PURGE — NOVOSCI CORP.Capiox® FX Advance Hollow Fiber Oxygenator w Integrated AF w Hardshell Res. — Terumo Cardiovascular Systems CorporationAffinity Pixie™ — MEDTRONIC, INC.Affinity Pixie™ — MEDTRONIC, INC.Terumo® PALL Arterial Filter — Terumo Cardiovascular Systems CorporationCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationAffinity Pixie™ — MEDTRONIC, INC.QUART — Maquet Cardiopulmonary AGMICRO — SORIN GROUP ITALIA SRLAffinity® — MEDTRONIC, INC.EMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLCINSPIRE — SORIN GROUP ITALIA SRLAFFINITY® — MEDTRONIC, INC.QUADROX-i — Maquet Cardiopulmonary AGAffinity™ — MEDTRONIC, INC.MICRO — SORIN GROUP ITALIA SRLMICRO — SORIN GROUP ITALIA SRLCapiox® FX Hollow Fiber Oxygenator w Integrated Arterial Filter w Hardshell Res. — Terumo Cardiovascular Systems CorporationTRILLIUM® Affinity® — MEDTRONIC, INC.PLEGIOX Heat Exchanger with Cardioplegia — Maquet Cardiopulmonary AGEMBOL-X Intra-Aortic Filter with Duraflo Coating — Edwards Lifesciences LLC
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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