Panels › Cardiovascular › Product code DTQ · Class 2

Console, Heart-Lung Machine, Cardiopulmonary Bypass

Regulation 870.4220

0510(k)s in 12 months (52 all time)

1recalls in 12 months (267 all time)

257recalls that name a 510(k)

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Top companies in DTQ

Company	510(k)s	Recalls
Terumo Cardiovascular Systems Corp.	7	204
Sorin Group USA, Inc.	0	28
Sorin Group Deutschland GmbH	8	7
Maquet Medical Systems USA	0	10
3M Health Care, Sarns	5	0
Maquet Cardiovascular Us Sales, Llc	0	5
Livanova Deutschland, GmbH	3	1
MAQUET Inc.	0	4
Maquet Cardiopulmonary, AG	2	2
Spectrum Medical , Ltd.	2	2

Date	Firm and product	Code	Linked 510(k)
Jul 7, 2007	Terumo Cardiovascular Systems Corp Terumo Perfusion System 8000 Roller Pump, 115V; Model 8000; Catalog No. 16402. Terminated	DTQ	K915183 K953904
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated	DTQ	None listed
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter (Large) Roller Pump; Model 801041. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter (small) Roller Pump; Model 801040. Terminated	DTQ	K022947
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	None listed
Jun 30, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; Air Bubble Detection Module; Catalog number 802110. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; CAPIOX Control Module; Catalog number 811113 (Not distributed within the United States). Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; Integrated (Sarns) Centrifugal System Control Unit; Catalog number 801046. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; Central Control Monitor; Catalog number 802100. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	K022947
Feb 14, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Feb 1, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog number 801046. Terminated	DTQ	K022947
Jan 9, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated	DTQ	K022947
Jan 9, 2007	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Flow Module; Catalog number 802018. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Central Control Monitor; Catalog number 802100. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Control Unit; Catalog number 801046. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Data Interface RS 485; Catalog number 803518. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Temperature Monitoring System; Catalog number 802114. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Pressure Monitoring; Catalog number 802112. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Level Detection; Catalog number 802111. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Venous Occluder; Catalog number 803480. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Data Interface CDI 500; Catalog number 803479. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Data Interface CDI 100; Catalog number 802558. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1 Air Bubble Detection Module; Catalog number 802110. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	K022947
Dec 30, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Dec 27, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base; Model 801764. (Not distributed within the United States). Terminated	DTQ	None listed
Dec 27, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763. Terminated	DTQ	K022947
Dec 27, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764. (Not distributed within the United States). Terminated	DTQ	K022947
Dec 27, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763. Terminated	DTQ	K022947
Dec 27, 2006	Terumo Cardiovascular Systems Corp Terumo Advanced Perfusion System 1; 220V -240V; Model 801764 (sold outside of the U.S. only). Terminated	DTQ	None listed

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