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

DateFirm and productCodeLinked 510(k)
Nov 10, 2025Medtronic Perfusion Systems
Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B
Open, Classified
DTZK241352
Feb 13, 2024Maquet Medical Systems USA
BEQ-HLS 7050 USA, HLS Set Advanced 7.0, Product Code/Part Number 70106.9078. Used with the CARDIOHELP heart-lung machine.
Open, Classified
DTZK112360
Feb 13, 2024Maquet Medical Systems USA
Model No. BEQ-HLS 5050 USA, HLS Set Advanced 5.0, Product Code/Part Number 70106.9077. Used with the CARDIOHELP heart-lung machine.
Open, Classified
DTZK112360
May 30, 2023Maquet Medical Systems USA
QUADROX-iR, used during cardiopulmonary bypass Model Item No. Description BEQ-HMO 51100-USA 701067936 Small Adult with filter, with BIOL
Open, Classified
DTZK102726
May 30, 2023Maquet Medical Systems USA
Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass Model Item No. VKMO 10000-USA 701070441 VKMO 11000-USA
Open, Classified
DTZK102919
May 30, 2023Maquet Medical Systems USA
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 10000-USA 701070412 HMO 11000-USA 701
Open, Classified
DTZK102464
May 30, 2023Maquet Medical Systems USA
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 70000-USA 701067820 HMO 71000-USA 7010678
Open, Classified
DTZK082117
May 30, 2023Maquet Medical Systems USA
QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. BEQ-HMOD30000-USA 701070397 BEQ-HMOD30000-USA 701050330
Open, Classified
DTZK100278
May 30, 2023Maquet Medical Systems USA
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. BEQ-HMO 50000-USA 701067905 HMO 50000-USA 701067891 HMO 51000-USA
Open, Classified
DTZK090689
May 30, 2023Maquet Medical Systems USA
QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Model Item No. HMOD 70000-USA 701067840 BEQ-HMOD70000-USA 701067859
Open, Classified
DTZK101153
May 30, 2023Maquet Medical Systems USA
QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass Model Item No. HMO 30000-USA 701070384 HMO 31000-USA 701070388
Open, Classified
DTZK103191
May 26, 2023Maquet Medical Systems USA
QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 10000-USA 701070412 HMO 11000-USA 701070416
Open, Classified
DTZK102464
May 26, 2023Maquet Medical Systems USA
BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067829
Open, Classified
DTZK090511
May 26, 2023Maquet Medical Systems USA
QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 70000-USA 701067820 HMO 71000-USA 701067823
Open, Classified
DTZK082117
May 26, 2023Maquet Medical Systems USA
QUADROX-i Small Adult, Oxygenator used during cardiopulmonary bypass Model Item no. HMO 50000-USA 701067891 HMO 51000-USA 701067895
Open, Classified
DTZK090689
May 26, 2023Maquet Medical Systems USA
BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass Item no. 701067905
Open, Classified
DTZK150267
May 26, 2023Maquet Medical Systems USA
BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass Item no. 701067859
Open, Classified
DTZK101153
May 26, 2023Maquet Medical Systems USA
HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass Item no. 701067840
Open, Classified
DTZK101153
Apr 5, 2023Terumo Cardiovascular Systems Corporation
CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC
Open, Classified
DTZK151791
Apr 5, 2023Terumo Cardiovascular Systems Corporation
CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE
Open, Classified
DTZK180950
Apr 5, 2023Terumo Cardiovascular Systems Corporation
CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30
Open, Classified
DTZK062381
Feb 28, 2023Maquet Medical Systems USA
BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code 70106.9077, BEQ-HLS 7050 USA; HLS Set Advanced 7.0, Product Code 70106.9078. Part of the CARDIOHELP System, a pre-connected set used for extr
Open, Classified
DTZK112360
Jan 27, 2023Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF CB811. Used in Cardiopulmonary bypass.
Open, Classified
DTZK203111
Jan 27, 2023Medtronic Perfusion Systems
Custom Pack Perfusion Tubing Packs containing Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, REF BB811. Used in Cardiopulmonary bypass.
Open, Classified
DTZK203111
Jan 27, 2023Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass.
Open, Classified
DTZK203111
Jan 27, 2023Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass.
Open, Classified
DTZK203111
Jan 27, 2023Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, OXY/CVR COMBO BB841 FUSION W/BALANCE 26L, REF BB841. Used in Cardiopulmonary bypass.
Open, Classified
DTZK203111
Jan 27, 2023Medtronic Perfusion Systems
Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass.
Open, Classified
DTZK203111
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70106.9078. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70106.9077. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 5050 USA; HLS Set Advanced 5.0 Part No. 70105.2797. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Jul 22, 2022Maquet Medical Systems USA
BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Part No. 70105.2794. A preconnected set used for extracorporeal respiratory and/or cardiovascular support, as part of the CARDIOHELP System.
Open, Classified
DTZK112360
Feb 3, 2022Abiomed, Inc.
OXY-1 System, Model Number 001-0500-001. Used during cardiopulmonary bypass. OXY-1 System consists of Console, Pump Drive, E Drive, and Pole Mount. The disposable Pump Lung Unit PLU part number
Terminated
DTZK200109
Nov 20, 2020Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced, Model: BEQ-HLS 7050 USA; HLS Set Advanced 7.0 Product Code/Part Number: 70105.2794 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extracorpore
Terminated
DTZK112360
Nov 20, 2020Maquet Cardiovascular Us Sales, Llc
HLS Set Advanced Model Name: BEQ-HLS 5050 USA; HLS Set Advanced 5.0, Product Code/Part Number: 70105.2797 - Product Usage: These devices are used with the CARDIOHELP system in order to provide extraco
Terminated
DTZK112360
Nov 11, 2020Terumo Cardiovascular Systems Corporation
(1) Capiox FX25 (West) Advance Oxygenator- with left port, 4-liter Reservoir, XC modified to Advance, Sterile Catalog Number: 3CX*FX25RWC (2) Capiox FX25 (East) Advance Oxygenator - FX25 with right
Terminated
DTZK151791
Nov 13, 2019GETINGE US SALES LLC
Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile REF: BEQ-HMOD 30000
Open, Classified
DTZK100278
Jul 11, 2019Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794
Terminated
DTZK112360
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator (West Orientation P/N:CXOT281 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Terminated
DTZK180950
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator (East Orientation), P/N: CXOT280 Exported only to Japan for inclusion into convenience kits that are sold only within the Japanese market
Terminated
DTZK180950
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation) P/N: 3CX*NX19RW
Terminated
DTZK180950
Jun 14, 2019Terumo Cardiovascular Systems Corporation
Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation) P/N: 3CX*NX19RE
Terminated
DTZK180950
Nov 28, 2018Maquet Cardiovascular Us Sales, Llc
QUADROX-i Neonatal with integrated arterial filter and VHK 11000 (VKMO 11000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055207 The membrane oxygenator QUADROXi Neonatal is intended for use in ext
Terminated
DTZK102464
K141432
Nov 28, 2018Maquet Cardiovascular Us Sales, Llc
QUADROX-i Neonatal without integrated arterial filter and VHK 11000 (VKMO 10000-USA#QUADROX-i Neo.+Reservoir), Part Number 701055120 The membrane oxygenator QUADROXi Neonatal is intended for use in
Terminated
DTZK102464
K141432
Aug 8, 2018Medtronic Perfusion Systems
Extra corporeal circuit with bio-active surface.
Terminated
DTZK891687
Mar 13, 2018LivaNova USA
Inspire 8 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050714 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 8M Holl
Terminated
DTZK130433
Mar 13, 2018LivaNova USA
Inspire 6 Integrated Phisio OXY w/ HVR Reservoir, Sterile EO, Catalog # 050713 The intended uses for the two elements that constitute the oxygenator/reservoir integrated devices are: INSPIRE 6M Hollo
Terminated
DTZK130209
Dec 20, 2016Medtronic Inc
Affinity Fusion" Oxygenator with Integrated Arterial Filter, Affinity Fusion cardiotomy/Venous Reservoir, Perfusion Tubing Packs The Affinity Fusion Oxygenator with Integrated Arterial Filter with or
Terminated
DTZK132972
K142784 +1
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
QUADROX-i oxygenators Custom tubing packs for the oxygenator
Terminated
DTZK082117
K090689 +4
May 28, 2015Maquet Cardiovascular Us Sales, Llc
Quadrox-iD Adult Diffusion Membrane Oxygenator Product Usage: The Quadrox-iD Adult Diffusion Membrane Oxygenator is intended for use in an extracorporeal circulation during cardiopulmonary bypass in
Terminated
DTZK132829

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