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)
Top companies in DTZ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 10, 2025 | Medtronic Perfusion Systems Affinity NT Oxygenator, Oxygenator with Balance Biosurface and Uncoated Cardiotomy/Venous Reservoir, Product Number 541B Open, Classified |
DTZ | K241352 |
| Feb 13, 2024 | Maquet 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 |
DTZ | K112360 |
| Feb 13, 2024 | Maquet 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 |
DTZ | K112360 |
| May 30, 2023 | Maquet 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 |
DTZ | K102726 |
| May 30, 2023 | Maquet Medical Systems USA Venous Hardshell Cardiotomy Reservoir, used during cardiopulmonary bypass
Model Item No.
VKMO 10000-USA 701070441
VKMO 11000-USA Open, Classified |
DTZ | K102919 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 10000-USA 701070412
HMO 11000-USA 701 Open, Classified |
DTZ | K102464 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 70000-USA 701067820
HMO 71000-USA 7010678 Open, Classified |
DTZ | K082117 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iD Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
BEQ-HMOD30000-USA 701070397
BEQ-HMOD30000-USA 701050330 Open, Classified |
DTZ | K100278 |
| May 30, 2023 | Maquet 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 |
DTZ | K090689 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMOD 70000-USA 701067840
BEQ-HMOD70000-USA 701067859 Open, Classified |
DTZ | K101153 |
| May 30, 2023 | Maquet Medical Systems USA QUADROX-i Pediatric, Oxygenator used during cardiopulmonary bypass
Model Item No.
HMO 30000-USA 701070384
HMO 31000-USA 701070388 Open, Classified |
DTZ | K103191 |
| May 26, 2023 | Maquet Medical Systems USA QUADROX -i Neonatal, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 10000-USA 701070412
HMO 11000-USA 701070416 Open, Classified |
DTZ | K102464 |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMO 71000-USA /QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067829 Open, Classified |
DTZ | K090511 |
| May 26, 2023 | Maquet Medical Systems USA QUADROX-i Adult, Oxygenator used during cardiopulmonary bypass
Model Item no.
HMO 70000-USA 701067820
HMO 71000-USA 701067823 Open, Classified |
DTZ | K082117 |
| May 26, 2023 | Maquet 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 |
DTZ | K090689 |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMO 50000-USA/ QUADROX-i Small, Oxygenator used during cardiopulmonary bypass
Item no. 701067905 Open, Classified |
DTZ | K150267 |
| May 26, 2023 | Maquet Medical Systems USA BEQ-HMOD70000-USA/QUADROX-iD, Oxygenator used during cardiopulmonary bypass
Item no. 701067859 Open, Classified |
DTZ | K101153 |
| May 26, 2023 | Maquet Medical Systems USA HMOD 70000-USA/QUADROX-iD Adult, Oxygenator used during cardiopulmonary bypass
Item no. 701067840 Open, Classified |
DTZ | K101153 |
| Apr 5, 2023 | Terumo Cardiovascular Systems Corporation CAPIOX FX25 Hollow Fiber Oxygenator, Catalog Numbers 3CX*FX25REC, 3CX*FX25RWC Open, Classified |
DTZ | K151791 |
| Apr 5, 2023 | Terumo Cardiovascular Systems Corporation CAPIOX NX19 Hollow Fiber Oxygenator, Catalog Number 3CX*NX19RE Open, Classified |
DTZ | K180950 |
| Apr 5, 2023 | Terumo Cardiovascular Systems Corporation CAPIOX RX15 Hollow Fiber Oxygenator, Catalog Number 3CX*RX15RE30 Open, Classified |
DTZ | K062381 |
| Feb 28, 2023 | Maquet 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 |
DTZ | K112360 |
| Jan 27, 2023 | Medtronic 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 |
DTZ | K203111 |
| Jan 27, 2023 | Medtronic 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 |
DTZ | K203111 |
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB841. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | K203111 |
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF CB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | K203111 |
| Jan 27, 2023 | Medtronic 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 |
DTZ | K203111 |
| Jan 27, 2023 | Medtronic Perfusion Systems Affinity Fusion Oxygenator with Integrated Arterial Filter and Balance Biosurface, Custom Packs, REF BB811. Used in Cardiopulmonary bypass. Open, Classified |
DTZ | K203111 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Jul 22, 2022 | Maquet 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 |
DTZ | K112360 |
| Feb 3, 2022 | Abiomed, 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 |
DTZ | K200109 |
| Nov 20, 2020 | Maquet 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 |
DTZ | K112360 |
| Nov 20, 2020 | Maquet 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 |
DTZ | K112360 |
| Nov 11, 2020 | Terumo 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 |
DTZ | K151791 |
| Nov 13, 2019 | GETINGE US SALES LLC Maquet Cardiopulmonary GmbH / Getinge Quadrox-iD Pediatric Diffusion Membrane Oxygenator with Bioline Coating, Sterile
REF: BEQ-HMOD 30000 Open, Classified |
DTZ | K100278 |
| Jul 11, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary (MCP)/Getinge HLS Set Advanced 7.0. Model Number BEQ-HLS-7050 USA, Part Number 701052794 Terminated |
DTZ | K112360 |
| Jun 14, 2019 | Terumo 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 |
DTZ | K180950 |
| Jun 14, 2019 | Terumo 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 |
DTZ | K180950 |
| Jun 14, 2019 | Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator With Reservoir (West Orientation)
P/N: 3CX*NX19RW Terminated |
DTZ | K180950 |
| Jun 14, 2019 | Terumo Cardiovascular Systems Corporation Terumo Capiox NX19 Oxygenator With Reservoir (East Orientation)
P/N: 3CX*NX19RE Terminated |
DTZ | K180950 |
| Nov 28, 2018 | Maquet 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 |
DTZ | K102464 K141432 |
| Nov 28, 2018 | Maquet 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 |
DTZ | K102464 K141432 |
| Aug 8, 2018 | Medtronic Perfusion Systems Extra corporeal circuit with bio-active surface. Terminated |
DTZ | K891687 |
| Mar 13, 2018 | LivaNova 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 |
DTZ | K130433 |
| Mar 13, 2018 | LivaNova 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 |
DTZ | K130209 |
| Dec 20, 2016 | Medtronic 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 |
DTZ | K132972 K142784 +1 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc QUADROX-i oxygenators
Custom tubing packs for the oxygenator Terminated |
DTZ | K082117 K090689 +4 |
| May 28, 2015 | Maquet 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 |
DTZ | K132829 |
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