ClearanceBrief
Panels › Cardiovascular › Product code DTZ · Class 2

Oxygenator, Cardiopulmonary Bypass

Regulation 870.4350

5510(k)s in 12 months (255 all time)
1recalls in 12 months (107 all time)
98recalls that name a 510(k)
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Top companies in DTZ

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.1221
Maquet Medical Systems USA022
Sorin Group Italia S.R.L.220
Medtronic162
Cobe Cardiovascular, Inc.88
Medtronic Perfusion Systems114
American Bentley130
Maquet Cardiopulmonary, AG130
Dideco120
Medtronic Vascular120
Decided510(k)Device and applicantCode
Sep 14, 2026K261438HORIZON 8AF (Integrated OXY MODULE 8AF and Horizon CVR) (US5305)
Eurosets S.R.L, IT
DTZ
Mar 16, 2026K253838Lifemotion Disposable Membrane Oxygenator
Lifemotion Medical Technology Co., Ltd., CN
DTZ
Mar 12, 2026K240934Quantum Perfusion Blood Oxygenator ECC VT160-E3 (VT160-E3); Quantum Perfusion Blood Oxygenator ECC VT200-E3 (VT200-E3);
Spectrum Medical S.R.L., IT
DTZ
Dec 12, 2025K250821Horizon AF Plus System (Integrated A.L. One AF Plus OXYGENATOR and Horizon CVR) (US5300); A.L. One AF Plus OXYGENATOR (U
Eurosets S.R.L, IT
DTZ
Nov 24, 2025K242503Trilly Pediatric Oxygenator with Integrated Arterial Filter (US5232)
Eurosets S.R.L, IT
DTZ
Sep 12, 2024K231982Quantum Perfusion Blood Oxygenator VT75-E1, Quantum Perfusion Blood Oxygenator VT75-E2
Qura S.R.L, IT
DTZ
Jul 10, 2024K240666Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface (BB811); Affinity Fusion Oxygenator wi
Medtronic Perfusion Systems
DTZ
Jun 12, 2024K241352Affinity NT Oxygenator and Uncoated Cardiotomy/ Venous Reservoir (541); Affinity NT Oxygenator with Balance Biosurface a
Medtronic, Inc.
DTZ
Nov 16, 2023K231652D100 KIDS; D101 KIDS
Sorin Group Italia S.R.L., IT
DTZ
Nov 8, 2023K231773Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT75-C1U, Quantum Perfusion Blood Oxygenator with Integ
Qura S.R.L, IT
DTZ
Nov 1, 2023K231414CMO8 Adult PMP Oxygenator with Tubing Pack (Model: CME40009)
Chalice Medical , Ltd., GB
DTZ
Apr 6, 2023K230640Affinity Fusion™ Oxygenator System
Medtronic, Inc.
DTZ
Feb 23, 2023K223161OXY-1 System
Abiomed, Inc.
DTZ
Dec 1, 2022K222297CentriMag Pre-connected Pack
Abbott
DTZ
Jan 28, 2022K212341Quantum Perfusion Blood Oxygenator with Integrated AF and Sensor VT200-C1U, Quantum Perfusion Blood Oxygenator with Inte
Qura S.R.L, IT
DTZ
Dec 17, 2021K203424Quantum Perfusion Blood Oxygenator ECC VT200-E1, Quantum Perfusion Blood Oxygenator ECC VT200-E2, Quantum Perfusion Bloo
Qura S.R.L, IT
DTZ
Dec 10, 2021K202510AMG PMP Infant
Eurosets S.R.L, IT
DTZ
Sep 16, 2021K203111Affinity Fusion Oxygenator System, Affinity Pixie Oxygenation System
Medtronic
DTZ
Jul 12, 2021K211495EOS PMP
Sorin Group Italia S.R.L., IT
DTZ
Apr 1, 2021K202206AMG PMP Pediatric
Eurosets S.R.L, IT
DTZ
Oct 23, 2020K200109OXY-1 System
Abiomed, Inc.
DTZ
Sep 18, 2020K201642Paragon Adult Maxi PMP Oxygenator with Tubing Pack
Chalice Medical , Ltd., GB
DTZ
Aug 13, 2020K201916Inspire 6M Hollow Fiber oxygenator, Inspire 7M Hollow Fiber oxygenator, Inspire 8M Hollow Fiber oxygenator
Sorin Group Italia S.R.L., IT
DTZ
Jun 12, 2020K200683INSPIRE 7FM Hollow fiber oxygenator with integrated arterial filter, INSPIRE 7F Hollow fiber oxygenator with integrated
Sorin Group Italia S.R.L., IT
DTZ
Feb 28, 2020K191246Paragon Adult Maxi PMP Oxygenator (Model: XCMOP405PMP)
Chalice Medical , Ltd., GB
DTZ
Sep 27, 2019K191444Affinity NT Oxygenator with Balance Biosurface, Affinity NT Oxygenator with Balance Biosurface and Uncoated Cardiotomy/V
Medtronic, Inc.
DTZ
May 17, 2019K191029Affinity NTTM Oxygenator (Model 511), Affinity® NT Hollow Fiber Oxygenator with Plasma Resistant Fiber (PRF) with Trilli
Medtronic, Inc.
DTZ
Apr 13, 2019K190690INSPIRE 7 Hollow Fiber Oxygenator with integrated Hardshell/Venous Cardiotomy Reservoir, INSPIRE 7M Hollow Fiber Oxygena
Sorin Group Italia S.R.L., IT
DTZ
Apr 12, 2019K183490Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Cortiva BioActive S
Medtronic, Inc.
DTZ
Mar 18, 2019K183511Affinity Pixie™ Oxygenator with Balance™ Biosurface (Model BBP211), Affinity Pixie™ Oxygenator and Cardiotomy/Venous Res
Medtronic, Inc.
DTZ
Jun 22, 2018K180950Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orie
Terumo Cardiovascular Systems Corporation
DTZ
Mar 29, 2018K172071Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west or
Terumo Cardiovascular Systems Corporation
DTZ
Mar 15, 2018K180448INSPIRE 6M Hollow Fiber Oxygenator; INSPIRE 6F M Hollow Fiber Oxygenator with Integrated Arterial Filter; INSPIRE 8M Hol
Sorin Group Italia S.R.L., IT
DTZ
Nov 20, 2017K172984Affinity Pixie Oxygenator with Balance Biosurface, Affinity Pixie Oxygenator with Cardiotomy/Venous Reservoir and Balanc
Medtronic, Inc.
DTZ
Oct 25, 2017K172626Affinity Fusion Oxygenator with Balance Biosurface, Affinity Fusion Oxygenator with Cardiotomy/Venous Reservoir and Bala
Medtronic, Inc.
DTZ
Dec 6, 2016K162896Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface
Medtronic, Inc.
DTZ
Sep 21, 2016K162016Affinity NT Oxygenator with Cortiva BioActive Surface
Medtronic, Inc.
DTZ
Feb 26, 2016K153295TandemLung Oxygenator
Cardiacassist, Inc.
DTZ
Dec 3, 2015K153213Capiox RX Hollow Fiber Oxygenator with/without Hardshell Reservoir
Terumo Cardiovascular Systems Corporation
DTZ
Dec 2, 2015K153140Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir, Terumo Capiox SX18 Oxygenator/ Hardshell Reservoir with Xcoating, Te
Terumo Cardiovascular Systems Corp.
DTZ
Nov 19, 2015K151791Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Reservoir, Terumo Capiox FX25 Advance Oxygenat
Terumo Cardiovascular Systems Corporation
DTZ
Nov 6, 2015K151713LILLIPUP PMP, LILLIPUT PMP INTEGRATED
Sorin Group Italia S.R.L., IT
DTZ
Oct 20, 2015K151389Terumo Capiox FX15 Advance Oxygenator with Integrated Arterial Filter and Hardshell Reservoir
Terumo Cardiovascular Systems Corporation
DTZ
Jun 11, 2015K150489EOS PMP, EOS PMP Integrated
Sorin Group Italia S.R.L., IT
DTZ
May 7, 2015K150267QUADROX-i Adult/Small Adult Oxygenators;QUADROX-iD Adult Oxygenators
Maquet Cardiopulmonary, AG, DE
DTZ
Mar 25, 2015K143073Affinity NT Oxygenator, Affinity NT Oxygenator with Trillium Biosurface, Affinity NT Oxygenator with Carmeda Biosurface
Medtronic, Inc.
DTZ
Feb 6, 2015K141492ADVANCED MEMBRANCE GAS EXCHANGE PMP STERILE (A.M.G PMP STERILE)
Eurosets S.R.L, IT
DTZ
Oct 24, 2014K142784Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Affinity Fusion Oxygenator with Integ
Medtronic, Inc.
DTZ
Jun 2, 2014K140774TERUMO CAPIOX FX15 AND FX25 HOLLOW FIBER OXYGENATOR/RESERVOIR
Terumo Cardiovascular Systems Corporation
DTZ
Feb 19, 2014K140181MEDOS HILITE INFANT OXYGENATOR
Medos Medizintechnik AG
DTZ

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