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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

DateFirm and productCodeLinked 510(k)
Jun 22, 2011Terumo Cardiovascular Systems Corporation
Pressure Monitoring Kit, Catalog 16066100, Terumo Cardiovascular Systems Ann Arbor MI. The pressure monitoring kit is indicated for sterile single use with the reusable pressure transducer.
Terminated
DTQK022947
K871131 +1
Mar 7, 2011Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, 220/240V System 1 Base, REF 801764, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. (not sold in the USA) The Terumo Advanced Perfusion System 1 is indicated fo
Terminated
DTQK022947
Mar 7, 2011Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, 100/120V System 1 Base, REF 801763, Terumo Cardiovascular Systems Corp., Ann Arbor, MI. The Terumo Advanced Perfusion System 1 is indicated for use in extracorporea
Terminated
DTQK022947
Feb 22, 2011Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary AG, MAQUET RPM 20: Roller Pump for Heart Lung Machine HL20.
Terminated
DTQK943803
Jan 26, 2011Sorin Group USA, Inc.
SRD S5 Mast Roller Pump System, S5 Component, Part No.: 50-80-60, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004 Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen,
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
S5 C5-System, Part No.: 58-00-00, Sorin Group Deutschland Gmbh, Lindberghstrasse, 25, Munchen, Germany, Sorin Group USA, 14401 W. 65th Way, Arvada, CO 80004. Used to perform, control and monitor ext
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
SRD S5 Mast Roller Pump System 85, S5 Component, Part No.: 50-80-70, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. Used to perform, control and monitor extracorporeal blo
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
2 S5 Mast Roller Pumps 85 with Double Holder, S5 Component, Part No.: 50-80-62, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. Used to perform, control and monitor extraco
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
SRD S5 Mast Roller Pump System 150, S5 Component, Part No.: 50-80-00, Made in Germany, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004. Used to perform, control and monitor extracorporeal bl
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
S5 Control Panel for 2 Mast Roller Pumps 85, Part No.: 28-95-85, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
S5 Mast Roller Pump System 85, Part No.: 28-95-80, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, co
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
S5 Display and Control Module, Part No.: 28-95-10, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany. Used to perform, control and monitor extracorporeal blood circulation during an
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
Stockert, S5 Double Roller Pump 85, Part No.: 10-85-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perfor
Terminated
DTQK060053
Jan 26, 2011Sorin Group USA, Inc.
Stockert, S5 Roller Pump 150, Part No.: 10-80-00, Sorin Group Deutschland Gmbh, Lindberghstrasse 25, Munchen, Germany, Sorin Group USA, Inc., 14401 W. 65th Way, Arvada, CO 80004. Used to perform, con
Terminated
DTQK060053
Jan 7, 2011Terumo Cardiovascular Systems Corporation
Occluder module, catalog 803480, Terumo Cardiovascular System Corp, Ann Arbor, MI. The occluder module is used with the Occluder head to provide a computer controlled tube clamping mechanism to regula
Terminated
DTQNone listed
Jan 7, 2011Terumo Cardiovascular Systems Corporation
Air bubble detect module, catalog 802110, Terumo Cardiovascular System Corp, Ann Arbor, MI. The air bubble detect module is used with an air sensor to detect gross air bubbles in the perfusion circuit
Terminated
DTQK022947
Sep 23, 2010Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, Catalog number 801764, 220/240V System 1 base, Terumo Cardiovascular System, Ann Arbor MI. (This product is not distributed in the US)
Terminated
DTQK022947
Sep 23, 2010Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, Catalog number 801763, 100/120V System 1 base, Terumo Cardiovascular System, Ann Arbor MI.
Terminated
DTQK022947
Jul 22, 2010Sorin Group USA, Inc.
B-Care 5, Catalog 25-60-00, for use with Sorin HLM C5 and HLM S5.
Terminated
DTQK092463
Jul 22, 2010Sorin Group USA, Inc.
Mast Roller Pump, Catalog 50-80-00, for use with Sorin HLM C5 and HLM S5.
Terminated
DTQK062396
May 29, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Central Control Monitor. Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802100. The Central Control Monitor (CCM) provides a centralized display of sy
Terminated
DTQK022947
Feb 24, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1; 220V -240V, 7A (circuit breaker), 50/60 Hz (10A power source required) base, Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801764. (Not distributed within th
Terminated
DTQK022947
Feb 24, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base. Terumo Cardiovascular Systems, Ann Arbor, MI. Model 801763. The device is indicate
Terminated
DTQK022947
Jan 29, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump, Terumo Cardiovascular Systems, Ann Arbor, MI; Model 801041. For use for up to 6 hours in the extracorporeal circulation of blood for ar
Terminated
DTQK022947
Jan 29, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Pressure Venous Occluder, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 803480. For use for up to 6 hours in the extracorporeal circulation of blood f
Terminated
DTQK022947
Jan 29, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Temperature Monitoring Systems, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802114. For use for up to 6 hours in the extracorporeal circulation of b
Terminated
DTQK022947
Jan 29, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Pressure Monitoring Unit, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802112. For use for up to 6 hours in the extracorporeal circulation of blood f
Terminated
DTQK022947
Jan 29, 2009Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Air Bubble Detection Module, Terumo Cardiovascular Systems, Ann Arbor, MI; Catalog number 802110. For use for up to 6 hours in the extracorporeal circulation of bloo
Terminated
DTQK022947
Dec 29, 2008Terumo Cardiovascular Systems Corporation
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
DTQK022947
Dec 29, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1; 100V -120V, 15 A (circuit breaker), 50/60 Hz (20A power source required) base; Model 801763.
Terminated
DTQK022947
Dec 11, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump, Gray; Model 816571). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced
Terminated
DTQK022947
Dec 11, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump, Gray; Model 816570). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced
Terminated
DTQK022947
Dec 11, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 (6 inch diameter Roller Pump; Model 801041). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Terminated
DTQK022947
Dec 11, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 (4 inch diameter Roller Pump; Model 801040). Extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures.
Terminated
DTQK022947
Dec 10, 2008Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II Pads. For use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900. Terumo Cardiovascular Systems Corp., Ann Arbor, MI.; REF 195240. Le
Terminated
DTQNone listed
Nov 25, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, 6 inch diameter Roller Pump; Model 801041. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusi
Terminated
DTQK022947
Nov 25, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1, 4 inch diameter Roller Pump; Model 801040. The Terumo(R) Advanced Perfusion System 1 is indicated for use in extracorpeal circulation of blood for arterial perfusi
Terminated
DTQK022947
Nov 7, 2008Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II (red) (Part # 195274) alarm level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular Sy
Terminated
DTQK871131
Nov 7, 2008Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II (yellow) (Part # 195215) alert level sensor transducer for use with Sarns Advanced Perfusion System I, Perfusion System 800 and Perfusion System 900; Terumo Cardiovascular
Terminated
DTQK871131
Nov 6, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This product is not distributed in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial
Terminated
DTQK022947
Nov 6, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Base, 100/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary by
Terminated
DTQK022947
Oct 31, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 base; Model 801764. NOTE: This device is not sold in the United States. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusio
Terminated
DTQK022947
Oct 31, 2008Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 base, 110/120V; Model 801763. For use for up to 6 hours in the extracorporeal circulation of blood for arterial perfusion, regional perfusion and cardiopulmonary by
Terminated
DTQK022947
Dec 1, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System 1 Integrated Centrifugal System Control Unit; Catalog Number 801046, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Terminated
DTQK022947
Dec 1, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System, 1 Roller Pump, 6 inch diameter; Catalog No. 801041, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Terminated
DTQK022947
Dec 1, 2007Terumo Cardiovascular Systems Corp
Terumo Advanced Perfusion System, 1 Roller Pump, 4 inch diameter; Catalog No. 801040, Terumo Cardiovascular Systems, Ann Arbor, MI 48103
Terminated
DTQK022947
Jul 23, 2007Medtronic Perfusion Systems
Medtronic Performer CPB-Universal R2100375. Catologue Number R5100052. The Performer CPB System is an electromechanical extracorporeal support device used during cardiopulmonary bypass procedures.
Terminated
DTQK052555
K070213
Jul 7, 2007Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Roller Pump, 1040V; Model 8000; Catalog No. 16411. (Not distributed within the United States).
Terminated
DTQNone listed
Jul 7, 2007Terumo Cardiovascular Systems Corp
Terumo Perfusion System 9000 Roller Pump; Model 9000; Catalog No. 16395.
Terminated
DTQK915183
K953904
Jul 7, 2007Terumo Cardiovascular Systems Corp
Terumo Perfusion System 8000 Roller Pump, 220/240V; Model 8000; Catalog No. 16407.
Terminated
DTQK915183
K953904

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