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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)
Dec 24, 2014Maquet Cardiovascular Us Sales, Llc
Maquet Quadrox-ID Pediatric Diffusion Membrane Oxygenator with Bioline Coating; Part Number BEQ-HMOD-30000 For cardiac surgery in combination with a heart lung machine to oxygenate blood, remove carb
Terminated
DTZK100278
Dec 16, 2014Medtronic Perfusion Systems
The Affinity Fusion Oxygenator with Integrated Arterial Filter and Carmeda Bioactive Surface is a single-use, microporous, hollow-fiber, gas-exchange device with plasma resistant fiber and integrated
Terminated
DTZK123314
K132972
Sep 20, 2013Maquet Cardiovascular Us Sales, Llc
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000. The QUADROX oxygenators are intended for use in extracorporeal circulation d
Terminated
DTZK082117
K090511 +4
Aug 27, 2013Medtronic Inc. Cardiac Rhythm Disease Management
Medtronic Custom Perfusion System with Carmeda BioActive Surface. Model Numbers: CB1D82R12 and CB5N73R7. Sterilized by Ethylene Oxide, Do no Reuse. Product Usage: Usage: This product is indica
Terminated
DTZK891687
Oct 26, 2012Maquet Cardiovascular Us Sales, Llc
QUADROX iD HMOD 2030 Diffusion Membrane Oxygenator; QUADROX-i ADULT HMO 70000 / HMO 71000; QUADROX-iD Pediatric HMOD 30000 Product Usage: The QUADROX oxygenators are intended for the use in extracor
Terminated
DTZK082117
K090511 +4
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RE40 Product Code:73673 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit- X-COATED PERFUSION PK FX15RW30 Product Code:73679 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 x1/2 pack Product Code:72015-05 Manufactured to the design and specifications of the purchaser/user) for the
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit- CUSTOM X-COATED LOW PRIME 3/8 Product Code:72015-04 Manufactured to the design and specifications of the purchaser/user) for the application it is intended
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-: CUSTOM X-COATED LOW PRIME Product Code:72015-03 Manufactured to the design and specifications of the purchaser/user) for the applica
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-PEDIATRIC PACK Product Code: 71062-01 Manufactured to the design and specifications of the purchaser/user) for the application it is intended.
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED PEDIATRIC 1/4X3/8 RX15 PACK Product Code:
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. Cardiovascular Custom Procedure Kit Adult Product Co
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15 ADULT PACK Product Code: 73399
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. X-COATED FX15RE40 PACK Product Code: 73484
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended FX15RE40 PACK Product Code:66031
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit-manufactured to the design and specifications of the purchaser/user) for the application it is intended. FX15RE40 PACK Product Code:66024
Terminated
DTZK071494
May 11, 2012Terumo Cardiovascular Systems Corp
Terumo Custom Cardiovascular Procedure Kit (manufactured to the design and specifications of the purchaser/user) for the application it is intended by the user. X-COATED CHANGE OUT PACK WITH FX15
Terminated
DTZK051997
K062381
Jan 24, 2012Terumo Cardiovascular Corporation
Terumo Cardiovascular Systems CAPIOX (r) SX18 Hollow Fiber Oxygenator LOT: HF22 . 2010-04 The X-coated Capiox SX18 Hollow Fiber Oxygenators with Detachable Hardshell Reservoir are used to exchange gas
Terminated
DTZK993772
Jan 18, 2012Medtronic Inc. Cardiac Rhythm Disease Management
Custom Packs/Mexico, Medtronic Cardio-Kit, Sterilized Using Ethylene Oxide, Nonpyrogenic, Rx Only. Model # DLP6N48R3 & DLP6N48R4. Medtronic Intersept Custom Tubing Pack with Trillium Biosurface,
Terminated
DTZK891687
Jan 14, 2012Sorin Group USA, Inc.
PTS Heart/Lung Perfusion Pack Labeling Sterile EO, Product is manufactured by Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004 (utilizing oxygenators manufactured by: Sorin Group Italia, Via
Terminated
DTZNone listed
Jan 14, 2012Sorin Group USA, Inc.
Synthesis PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12
Terminated
DTZK073380
Jan 14, 2012Sorin Group USA, Inc.
PRIMO2X Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86,
Terminated
DTZK050447
Jan 14, 2012Sorin Group USA, Inc.
D 905 EOS Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 8
Terminated
DTZK043323
Jan 14, 2012Sorin Group USA, Inc.
D 903 Avant Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord,
Terminated
DTZK033323
Jan 14, 2012Sorin Group USA, Inc.
Apex HP PHisio SMART Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale
Terminated
DTZK083021
Jan 14, 2012Sorin Group USA, Inc.
Apex HP PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 No
Terminated
DTZK083021
Jan 14, 2012Sorin Group USA, Inc.
Apex HP Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86,
Terminated
DTZK092895
Jan 14, 2012Sorin Group USA, Inc.
Apex Phisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord,
Terminated
DTZK020997
Jan 14, 2012Sorin Group USA, Inc.
Apex SMART PHisio Oxygenator extracorporeal membrane, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12
Terminated
DTZK020997
Jan 14, 2012Sorin Group USA, Inc.
Apex Oxygenator, Sterile EO, Distributed in U.S. by: Sorin Group USA, Inc, 14401 W. 65th Way, Arvada, CO 80004, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy
Terminated
DTZK014080
Jan 11, 2012Maquet Cardiovascular Us Sales, Llc
MAQUET QUADROX iD PEDIATRIC -OXYGENATOR: BEQ-HMOD 3000; Made In Germany The diffusion membrane oxygenator Quadrox iD pediatric is intended for use in an extracorporeal perfusion system. The oxygenato
Terminated
DTZK100278
Feb 9, 2009Medtronic Inc
Medtronic Surgical Membrane Oxygenator. Mis-printed Label: Medtronic 1-4500-2A, Recommended maximum blood flow range 5.0 - 8.5 L/min, Sterilized Using Ethylene Oxide, REF 61399402655, Manufacture
Terminated
DTZNone listed
Nov 9, 2008Navilyst Medical
NAMIC Custom Angiographic Kit, Right Heart Kit, REF/Catalog # 60190254, Sterile, and bulk Non-Sterile Manifolds Assemblies, Product #s 40338200 and 40336200 (foreign product for further processing, e.
Terminated
DTZK782095
Sep 30, 2008Sorin Group USA, Inc.
Dideco, D901 Lilliput 1, Close Phisio, Sterile EO, REF 05252, Manufacturer: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) (Italy). The product is intended for use in cardiopulmon
Terminated
DTZK991737
Jul 24, 2008Medtronic Perfusion Systems
Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4.
Terminated
DTZK000430
Jul 24, 2008Medtronic Perfusion Systems
Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12,
Terminated
DTZK891687
Jan 26, 2008Medtronic Perfusion Systems
Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604.
Terminated
DTZK936003
K973760
Jul 26, 2007Medtronic Perfusion Systems
Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN
Terminated
DTZK926226
May 24, 2007Integra LifeSciences Corp.
EnDura No-React Dural Substitute 12 cm Diameter
Terminated
DTZNone listed
May 24, 2007Integra LifeSciences Corp.
EnDura No React Dural Substitute 10 cm x 12 cm
Terminated
DTZNone listed
May 24, 2007Integra LifeSciences Corp.
Endura No-React Dural Substitute 6 cm x 10 cm
Terminated
DTZNone listed
May 24, 2007Integra LifeSciences Corp.
EnDura No-React Dural Substitute 4 cm X 4 cm.
Terminated
DTZNone listed
May 24, 2007Integra LifeSciences Corp.
Endura No-React Dural Substitute 2 cm x 10 cm
Terminated
DTZNone listed
Aug 24, 2006Cobe Cardiovascular, Inc
Cobe CML Duo Flat Sheet Membrane Oxygenator, Non-sterile, Catalog Number: 436122974, COBE Cardiovascular, Inc..-(shipped international only for use in Heart/Lung Packs)
Terminated
DTZNone listed
Aug 24, 2006Cobe Cardiovascular, Inc
Cobe Optima XP Hollow Fiber Membrane Oxygenator, Non-Sterile, Catalog Number 436422974, COBE Cardiovascular, Inc.. (shipped International only for use in Heart/Lung packs)
Terminated
DTZNone listed
Aug 24, 2006Cobe Cardiovascular, Inc
Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc..
Terminated
DTZK013480
K991452
Aug 24, 2006Cobe Cardiovascular, Inc
Cobe CML Duo Flat Sheet Membrane Oxygenator, sterile, (Custom Heart/Lung Packs), Catalog numbers: 067100001, 078002103, 078005802, 078159025, 078201013, 078212009, 078310006, 078332022, 078348014, 07
Terminated
DTZK000255
K963518
Aug 24, 2006Cobe Cardiovascular, Inc
Cobe Optima XP Hollow Fiber Membrane Oxygenator, Sterile, (Custom Heart/Lung Packs), Catalog Numbers: 028901008, 032794001, 067129002, 067149006, 067174002, 067188002, 067212004, 067221009, 067236004,
Terminated
DTZK926467
K974812
Aug 24, 2006Cobe Cardiovascular, Inc
Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc..
Terminated
DTZK013480
K991452

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