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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

Company510(k)sRecalls
Terumo Cardiovascular Systems Corp.7204
Sorin Group USA, Inc.028
Sorin Group Deutschland GmbH87
Maquet Medical Systems USA010
3M Health Care, Sarns50
Maquet Cardiovascular Us Sales, Llc05
Livanova Deutschland, GmbH31
MAQUET Inc.04
Maquet Cardiopulmonary, AG22
Spectrum Medical , Ltd.22
DateFirm and productCodeLinked 510(k)
Dec 27, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
Terminated		 DTQK022947
Dec 19, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Electronic Oxygen Blender/analyzer; Catalog number 801188.
Terminated		 DTQK022947
Nov 7, 2006MAQUET Inc.
Jostra HL-20 Heart Lung Machine - guiding pins
Terminated		 DTQK943803
Nov 7, 2006MAQUET Inc.
Jostra - HL-20 Heart Lung Integrated Perfusion System, Roller Pump Hand crank
Terminated		 DTQK943803
Aug 22, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog No. 801046.
Terminated		 DTQNone listed
Aug 22, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Roller Pump 4 inch diameter; Catalog No. 801040.
Terminated		 DTQK022947
Aug 22, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Roller Pump 6 inch diameter; Catalog No. 801041.
Terminated		 DTQK022947
Jul 27, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Large Roller Pump; Model 801041.
Terminated		 DTQK022947
Jul 27, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 4 inch diameter Roller Pump; Model 801040.
Terminated		 DTQK022947
Jul 27, 2006Terumo 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		 DTQK022947
Jul 27, 2006Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Models 801763 and 801763 (Japan unit).
Terminated		 DTQK022947
Mar 31, 2005Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 (with 6 inch diameter roller pump); Catalog number 801041.
Terminated		 DTQK022947
Mar 31, 2005Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 (with 4 inch diameter roller pump); Catalog number 801040.
Terminated		 DTQK022947
Nov 18, 2004Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required); Model 801764.
Terminated		 DTQK022947
Nov 18, 2004Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required); Model 801763.
Terminated		 DTQK022947
Nov 7, 2003Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Roller Pump; 6 inch diameter; Catalog number 801040.
Terminated		 DTQK022947
Nov 7, 2003Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Roller Pump; 4 inch diameter; Catalog number 801040.
Terminated		 DTQK022947

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