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Panels › Cardiovascular › Product code DTR · Class 2

Heat-Exchanger, Cardiopulmonary Bypass

Regulation 870.4240

1510(k)s in 12 months (91 all time)
2recalls in 12 months (35 all time)
27recalls that name a 510(k)
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Top companies in DTR

DateFirm and productCodeLinked 510(k)
Sep 29, 2026SPECTRUM MEDICAL SRL
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 Model/Catalog Number: HX55W-S0 Software Version: N/A Product Description: The Quantum PureFlow Standar
Open, Classified
DTRK220110
K223879
Sep 29, 2026SPECTRUM MEDICAL SRL
Brand Name: Quantum PureFlow Product Name: Quantum PureFlow Standard Heat Exchanger High Flow 3/8 W Model/Catalog Number: HX55V-S0W Software Version: N/A Product Description: The Quantum PureFlow Stan
Open, Classified
DTRK220110
K223879
May 26, 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
DTRK103191
Dec 17, 2019Quest Medical, Inc.
Ref 801168, MPS Top Cover Replacement Kit, 1 UNITS, UDI: (01)2 0634624 81168 7 (11)190916 (17)290913 (10)059135 (The device is a component of the MPS Console used as replacements for worn or damaged
Terminated
DTRK173716
Dec 2, 2015Quest Medical, Inc.
Model 5001102 MPS Delivery Set w/ arrest agent and additive cassettes, heat exchanger &10 ft. delivery tubing; Model 5001102-AS MPS Delivery Set with 6 ft. delivery tubing; Model 7001102 MPS Low Volum
Terminated
DTRK953838
Oct 31, 2014Terumo Cardiovascular Systems Corp
Terumo Cardioplegia Delivery Set- Item Number: 16130 Product Usage: The Cardioplegia Delivery Sets are indicated for delivery of cardioplegic solutions to the heart during cardiopulmona
Terminated
DTRK823451
Oct 31, 2014Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Set - Heat Exchanger Cardiopulmonary Bypass Item Numbers: 5852, 16010 Product Usage: This is a Cardioplegia Delivery System that is designed to delivery blood/s
Terminated
DTRK900640
Oct 31, 2014Terumo Cardiovascular Systems Corp
Terumo Custom Cardioplegia Delivery Sets Catalog Code: 204880 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets-and includes the female luer connector" that is the sub
Terminated
DTRK897039
Mar 10, 2014Maquet Cardiovascular Us Sales, Llc
MAQUET PLEGIOX Cardioplegia Heat Exchanger The PLEGIOX Cardioplegia Heat Exchanger is used as part of a cardioplegia system to set and maintain temperature for given flow rates and within the given t
Terminated
DTRK090555
Apr 8, 2011Quest Medical, Inc
Quest MPS and MPS 2 Consoles, Quest Medical, Inc., An Atrion company. Single software controlled device that incorporates a pump, a heater/cooler, temperature monitoring, pressure monitoring, a heat
Terminated
DTRK041979
K953838
Sep 29, 2010Terumo Cardiovascular Corporation
Cardiovascular Procedure Kit X-Coated H/L pack with Cardioplegia, Item # 70067-03
Terminated
DTRNone listed
Sep 29, 2010Terumo Cardiovascular Corporation
Cardiovascular Procedure Kit Custom 4:1 Myocardial Set, (MP4 w/ Coil Component Utilized), Item # 63485
Terminated
DTRNone listed
Sep 29, 2010Terumo Cardiovascular Corporation
Cardiovascular Procedure Kit, (MP4 w/ Conducer Component Utilized), labeled in part ***RWJ Hospital***, Item # 71305-03
Terminated
DTRK900640
Sep 29, 2010Terumo Cardiovascular Corporation
Cardiovascular Procedure Kit X-Coated Pump and Table Pack, Item #71552
Terminated
DTRNone listed
Sep 29, 2010Terumo Cardiovascular Corporation
Sarns Cardioplegia Set CPLG BLD MP4 4:1 No recirculation, Item # 16010
Terminated
DTRNone listed
Sep 29, 2010Terumo Cardiovascular Corporation
Sarns Cardioplegia Set with w/ PVC Coil from MP4, Item # 15501
Terminated
DTRNone listed
Sep 29, 2010Terumo Cardiovascular Corporation
Sarns Cardioplegia Set with Conducer Heat Exchanger Cplg/MP4 4:1, Item # 165720
Terminated
DTRNone listed
Sep 29, 2010Terumo Cardiovascular Corporation
Sarns Cardioplegia Set Conducer Heat Exchanger Cplg/MP4 4:1 Bridge, Item# 6375
Terminated
DTRNone listed
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom CONDUCER/MP4 8:1 NO RECIRC. DOUBLE SPIKE P/N: 71032
Terminated
DTRK900640
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED HEART - LUNG PACK P/N: 70608-01
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N: 131351-02
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PACK P/N 72846
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED MASTER PACK P/N 72790
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED PUMP AND TABLE PACK W/8:1 CARDIOPLEGIA P/N 72642
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED PERFUSION PACK P/N 71934
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED HEART/LUNG FRAMEPACK P/N 71766PP
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom PERFUSION TUBING PACK P/N 71733
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom ADULT PACK P/N 71546-01
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom X-COATED ADULT PRESTIGE PACK P/N 71544-01
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom 8:1 CARDIOPLEGIA SET P/N 70608-01
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom MP4, 4:1, PRELIEF, W/RECIRC, COND / PUMP & TABLE PACK P/N 65503/70881-02
Terminated
DTRK823451
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom 1:1 CONDUCER/MP4 CRYSTALLOID CARDIOPLEGIA P/N 65246
Terminated
DTRK900640
Aug 2, 2010Terumo Cardiovascular Systems Corp
Terumo Cardiovascular Procedure Kit Custom Open Perfusion Pack P/N 64937
Terminated
DTRK823451
Apr 3, 2003Terumo Cardiovascular Systems Corp
Heat Exchanger Coil (code Number 0006-0011) used in the ''Custom Cardiovascular Procedure Kits'' .
Terminated
DTRK000977
Mar 20, 2003Terumo Cardiovascular Systems Corp
Sarns MP4 Cardioplegia Sets; catalog number 15501.
Terminated
DTRNone listed

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