Console, Heart-Lung Machine, Cardiopulmonary Bypass

FDA product code DTQ · 48 cleared devices

Class 2 Cardiovascular

Regulation: 21 CFR 870.4220
Review panel: CV
Implant: No
Life sustaining: Yes
Third party review: No
GMP exempt: No
Clearance span: 1977-03-07 – 2023-08-24

DTQ 2023-08-24

Essenz HLM, Essenz ILBM

Applicant Livanova Deutschland, GmbH

K number K232291

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DTQ 2023-04-18

Terumo Advanced Perfusion System 1

Applicant Terumo Cardiovascular Systems Corporation

K number K221895

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DTQ 2023-03-09

Essenz HLM

Applicant Livanova Deutschland, GmbH

K number K221373

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DTQ 2021-04-05

Stockert S5 System

Applicant Livanova Deutschland, GmbH

K number K210130

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DTQ 2021-03-07

Century Perfusion System

Applicant Century Hlm, LLC

K number K202125

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DTQ 2019-05-24

Quantum Smart Occluder LH (left-hand), Quantum Smart Occluder LH (right-hand)

Applicant Spectrum Medical , Ltd.

K number K190282

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DTQ 2018-05-25

Quantum Pump Console

Applicant Spectrum Medical , Ltd.

K number K173834

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DTQ 2017-08-17

Advanced Perfusion System 1

Applicant Terumo Cardiovascular Systems Corporation

K number K172220

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DTQ 2017-06-07

Advanced Perfusion System 1

Applicant Terumo Cardiovascular Systems Corporation

K number K163531

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DTQ 2011-04-04

CARDIOHELP SYSTEM

Applicant Maquet Cardiopulmonary, AG

K number K102726

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DTQ 2011-01-20

SORIN C5 SYSTEM; 85/C5 MAST ROLLER PUMP SYSTEM 150(1X RP 150 AND CONTROL PANEL WITH CONNECTING CABLES); S5/C5 MAST ROLLE

Applicant Sorin Group Deutschland GmbH

K number K103762

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DTQ 2010-01-15

SORIN C5 SYSTEM MODEL 58-00-00

Applicant Sorin Group Deutschland GmbH

K number K093882

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DTQ 2009-11-05

SORIN B-CARE5 FOR THE STOCKERT S5 SYSTEM

Applicant Sorin Group Deutschland GmbH

K number K092463

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DTQ 2009-10-15

LIFEBRIDGE B2T, MODEL 7001

Applicant Lifebridge Medizintechnik AG

K number K090006

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DTQ 2009-07-02

AIR PURGE CONTROL SYSTEM FOR S5 SYSTEM MODEL 23-45-05

Applicant Sorin Group Deutschland GmbH

K number K091007

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DTQ 2008-07-30

STOCKERT S5 SYSTEM, STOCKERT GAS BLENDER

Applicant Sorin Group Deutschland GmbH

K number K080832

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DTQ 2007-07-06

MODIFICATION TO: STOCKERT S5 SYSTEM

Applicant Sorin Group Deutschland GmbH

K number K071318

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DTQ 2007-03-21

PERFORMER CBP SYSTEM

Applicant Rand S.R.L.

K number K070213

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DTQ 2006-09-28

MODIFICATION TO STOCKERT S5 SYSTEM

Applicant Sorin Group Deutschland GmbH

K number K062396

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DTQ 2006-06-02

STOCKERT S5 SYSTEM

Applicant Sorin Group Deutschland GmbH

K number K060053

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DTQ 2006-03-15

MEDTRONIC PERFORMER TM CPB, MODEL R51, PCPB

Applicant Rand S.R.L.

K number K052555

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DTQ 2003-03-20

ADVANCED PERFUSION SYSTEM 1 (100/120 VOLT),ADVANCED PERFUSION SYSTEM 1 (220/240 VOLT, ROLLER PUMPS (6, 4 INCH

Applicant Terumo Cardiovascular Systems Corp.

K number K022947

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DTQ 2003-02-26

MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-100

Applicant Cardiovention, Inc.

K number K030141

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DTQ 2003-01-08

CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100

Applicant Cardiovention, Inc.

K number K021694

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DTQ 2002-09-23

STOCKERT CENTRIFUGAL PUMP CONSOLE

Applicant Stockert Instrumente GmbH

K number K020571

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DTQ 2001-05-02

SIII ALARM AMPLIFIER

Applicant Stockert Instrumente GmbH

K number K011088

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DTQ 2000-08-09

STOCKERT COMPACT SYSTEM VERSION 2.0

Applicant Stoeckert Instrumente

K number K002118

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DTQ 2000-08-09

S3 CARDIOPLEGIA CONTROL MODULE VERSION 2.0

Applicant Medical Device Consultants, Inc.

K number K002116

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DTQ 1998-09-04

STOCKERT COMPACT SYSTEM

Applicant Stoeckert Instrumente

K number K982014

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DTQ 1997-08-05

AFFINITY BLOOD PUMP SYSTEM

Applicant Avecor Cardiovascular, Inc.

K number K964017

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DTQ 1996-01-30

JOSTRA HL-20 INTEGRATED PERFUSION SYSTEM

Applicant Janus Biomedical, Inc.

K number K943803

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DTQ 1996-01-19

STOCKERT S3 ROLLER PUMP MODULE STOCKERT S3 CONSOLE

Applicant Stoeckert Instrumente

K number K950990

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DTQ 1995-01-27

SORIN BLOOD CARDIOPLEGIA CONSOLE

Applicant Sorin Biomedical, Inc.

K number K942582

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DTQ 1992-07-08

SARNS 8000 MODULAR PERFUSION SYSTEM

Applicant 3M Health Care, Sarns

K number K915183

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DTQ 1987-05-21

SARNS 9000 HEART-LUNG CONSOLE

Applicant 3M Health Care, Sarns

K number K871131

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DTQ 1987-05-06

ONGUARD 1000, CATALOG #043611-000 & 043611-001

Applicant Cobe Laboratories, Inc.

K number K870976

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DTQ 1986-12-11

STOCKERT-SHILEY CAPS BATTERY MODULE

Applicant Shiley, Inc.

K number K863960

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DTQ 1986-11-18

STOCKERT-SHILEY CAPS HLM INTERFACE

Applicant Shiley, Inc.

K number K863541

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DTQ 1986-10-01

STOCKERT-SHILEY CAPS TIMER MODULE

Applicant Shiley, Inc.

K number K862973

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DTQ 1986-06-23

SARNS PORTABLE POWER MODULE

Applicant 3M Health Care, Sarns

K number K861388

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DTQ 1985-06-19

CENTRIMED SYSTEM 1 W/MANUAL PUMP DRIVE

Applicant Centrimed Corp.

K number K851615

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DTQ 1985-06-19

CENTRIMED SYSTEM 1 W/24 VOLT BATTERY POWER SUPPLY

Applicant Centrimed Corp.

K number K851614

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DTQ 1984-08-03

COBE EMERGENCY POWER SOURCE 43610-000

Applicant Cobe Laboratories, Inc.

K number K842138

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DTQ 1982-08-24

GAMBRO PUMP CONSOLE CSL

Applicant Gambro, Inc.

K number K822068

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DTQ 1981-11-27

POLYSTAN HEART LUNG MACHINE SYS

Applicant Advocacy International, Ltd.

K number K813034

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DTQ 1980-05-20

SARNS 7000 MONITOR MODULE

Applicant 3M Health Care, Sarns

K number K801097

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DTQ 1977-11-02

SARNES HELP

Applicant 3M Health Care, Sarns

K number K772001

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DTQ 1977-03-07

CONSOLE, MOBILE FOR 3 PUMPS W/MASTS

Applicant Cobe Laboratories, Inc.

K number K770002

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