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) |
|---|---|---|---|
| Dec 24, 2014 | Maquet 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 |
DTZ | K100278 |
| Dec 16, 2014 | Medtronic 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 |
DTZ | K123314 K132972 |
| Sep 20, 2013 | Maquet 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 |
DTZ | K082117 K090511 +4 |
| Aug 27, 2013 | Medtronic 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 |
DTZ | K891687 |
| Oct 26, 2012 | Maquet 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 |
DTZ | K082117 K090511 +4 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K071494 |
| May 11, 2012 | Terumo 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 |
DTZ | K051997 K062381 |
| Jan 24, 2012 | Terumo 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 |
DTZ | K993772 |
| Jan 18, 2012 | Medtronic 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 |
DTZ | K891687 |
| Jan 14, 2012 | Sorin 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 |
DTZ | None listed |
| Jan 14, 2012 | Sorin 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 |
DTZ | K073380 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K050447 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K043323 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K033323 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K083021 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K083021 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K092895 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K020997 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K020997 |
| Jan 14, 2012 | Sorin 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 |
DTZ | K014080 |
| Jan 11, 2012 | Maquet 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 |
DTZ | K100278 |
| Feb 9, 2009 | Medtronic 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 |
DTZ | None listed |
| Nov 9, 2008 | Navilyst 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 |
DTZ | K782095 |
| Sep 30, 2008 | Sorin 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 |
DTZ | K991737 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic AFFINITY NT Hollow Fiber Oxygenator with Plasma Resistant fiber with Carmeda BioActive Surface, Catalog Number: CB511, CB5201R14, and CB5227R4. Terminated |
DTZ | K000430 |
| Jul 24, 2008 | Medtronic Perfusion Systems Medtronic Extracorporeal Circuit with bio-active surface; Cardiopulmonary Bypass Oxygenator, Catalog Numbers: CB0B90R3, CB0L44R15, CB0X97R10, CB1V99R2, CB1Y06R14, CB1Z42R15, CB1Z69R12, CB1Z69R12, Terminated |
DTZ | K891687 |
| Jan 26, 2008 | Medtronic Perfusion Systems Medtronic Trillium Affinity NT, 541T, Integrated CVR/Membrane Oxygenator (Plasma Resistant Fiber [PRF] Medtronic, Inc., Minneapolis, MN 55432-5604. Terminated |
DTZ | K936003 K973760 |
| Jul 26, 2007 | Medtronic Perfusion Systems Medtronic Intersept Filtered Cardiotomy Reservoir, Model 1351, Non-pyrogenic, Sterile, Manufacturer: Medtronic, Inc., Minneapolis, MN Terminated |
DTZ | K926226 |
| May 24, 2007 | Integra LifeSciences Corp. EnDura No-React Dural Substitute 12 cm Diameter Terminated |
DTZ | None listed |
| May 24, 2007 | Integra LifeSciences Corp. EnDura No React Dural Substitute 10 cm x 12 cm Terminated |
DTZ | None listed |
| May 24, 2007 | Integra LifeSciences Corp. Endura No-React Dural Substitute 6 cm x 10 cm Terminated |
DTZ | None listed |
| May 24, 2007 | Integra LifeSciences Corp. EnDura No-React Dural Substitute 4 cm X 4 cm. Terminated |
DTZ | None listed |
| May 24, 2007 | Integra LifeSciences Corp. Endura No-React Dural Substitute 2 cm x 10 cm Terminated |
DTZ | None listed |
| Aug 24, 2006 | Cobe 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 |
DTZ | None listed |
| Aug 24, 2006 | Cobe 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 |
DTZ | None listed |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Sterile, (Custom Heart / Lung Pack), Catalog Numbers: 067350004, 067734001, 067736002. COBE Cardiovascular, Inc.. Terminated |
DTZ | K013480 K991452 |
| Aug 24, 2006 | Cobe 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 |
DTZ | K000255 K963518 |
| Aug 24, 2006 | Cobe 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 |
DTZ | K926467 K974812 |
| Aug 24, 2006 | Cobe Cardiovascular, Inc Cobe Optimin Hollow Fiber Sealed System, Oxygenator/Reservoir, Sterile, (Standalone systems), Catalog numbers:050125400, 050502000. COBE Cardiovascular, Inc.. Terminated |
DTZ | K013480 K991452 |
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