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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)
Mar 1, 2013Salyer Prn Biomedical
Century Console Base, Model #043625051b. Intended for use as a platform for other ancillary equipment and disposable products in cardiopulmonary surgical procedures.
Terminated
DTQNone listed
Nov 27, 2012Terumo Cardiovascular Systems Corporation
220/240V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQK022947
Nov 27, 2012Terumo Cardiovascular Systems Corporation
100/120V AC, Advanced Perfusion System Platform (APS) The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQK022947
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQK915183
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQK915183
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for ar
Terminated
DTQK915183
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for ar
Terminated
DTQK915183
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQK915183
Nov 13, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arteria
Terminated
DTQK915183
Nov 8, 2012Sorin Group USA, Inc.
Sorin C5 Perfusion System, Item number 58-00-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Mast Roller Pump 150, Item Number: 10-88-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Mast Roller Pump 85, Item Number: 10-88-60 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Double Roller Pump 85, Item Number: 10-85-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Nov 8, 2012Sorin Group USA, Inc.
S5 Single Roller Pump 150, Item Number: 10-80-00 The Stockert S5/Sorin C5 System is intended to be used during cardiopulmonary bypass for procedures lasting six hours or less.
Terminated
DTQK071318
K093882
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQK915183
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 100V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQK915183
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for art
Terminated
DTQK915183
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 220V/240V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for art
Terminated
DTQK915183
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 5 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQK915183
Oct 24, 2012Terumo Cardiovascular Systems Corporation
Perfusion System 8000, base 4 pump, 115V safety monitor included The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial
Terminated
DTQK915183
Sep 25, 2012Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 Flow Module indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures only when use
Terminated
DTQK022947
Sep 24, 2012Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 ASSEMBLY FLOW POD Product Usage: The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional
Terminated
DTQK022947
Sep 11, 2012Terumo Cardiovascular Systems Corporation
Safety monitor included with System 8000 Base The Sarns" Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, region
Terminated
DTQK915183
Aug 21, 2012Terumo Cardiovascular Systems Corporation
Interface module for CDl System 500 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Communica
Terminated
DTQK022947
Aug 21, 2012Terumo Cardiovascular Systems Corporation
Interface module for CDl System 100/101 Product Usage: The Interface Module for CDl 500 is the interface between the CDl 500 monitor and the system. The module performs the following functions: Commu
Terminated
DTQK022947
Aug 21, 2012Terumo Cardiovascular Systems Corporation
Serial interface module RS-485 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is
Terminated
DTQK022947
Aug 21, 2012Terumo Cardiovascular Systems Corporation
Serial interface module RS-232 Product Usage: The System 1 provides perfusion case data transfer through the use of the data transfer module. This module is a general purpose serial interface and is
Terminated
DTQK022947
Aug 16, 2012Terumo Cardiovascular Systems Corporation
System 8000 Base Product Usage: The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, a
Terminated
DTQK915183
Aug 9, 2012Terumo Cardiovascular Systems Corporation
System 1 base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced
Terminated
DTQK022947
Aug 9, 2012Terumo Cardiovascular Systems Corporation
System 1 base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass proced
Terminated
DTQK022947
Jul 20, 2012Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop
Terminated
DTQK022947
Jul 20, 2012Terumo Cardiovascular Systems Corporation
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop
Terminated
DTQK022947
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 100V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion,
Terminated
DTQK871131
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 220/240V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusi
Terminated
DTQK871131
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 9000, 115V with color screen. The Sarns Perfusion System 9000 is indicated for use as a heart-lung system for pumping blood for arterial perfusion, regional perfusion,
Terminated
DTQK871131
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 100V. he Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion,
Terminated
DTQK915183
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 100V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion
Terminated
DTQK915183
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfu
Terminated
DTQK915183
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 220/240V. The Sarns Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfu
Terminated
DTQK915183
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 5 pump 115V. The Sarns Modular Perfusion Systern 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusio
Terminated
DTQK915183
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Sarns Modular Perfusion System 8000 base, 4 pump 115V. The Sarns Modular Perfusion system 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion
Terminated
DTQK915183
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1. System 1 base 220/240V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfus
Terminated
DTQK022947
Jul 19, 2012Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1. System 1 base 100/120V. The Terumo Advanced Perfusion System I is indicated for use in extracorporeal circulation of blood for arterial perfusion, regional perfus
Terminated
DTQK022947
Jul 17, 2012Terumo Cardiovascular Systems Corporation
System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardi
Terminated
DTQK022947
Jul 17, 2012Terumo Cardiovascular Systems Corporation
System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardi
Terminated
DTQK022947
Jul 13, 2012Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf
Terminated
DTQK022947
Jul 13, 2012Terumo Cardiovascular Systems Corporation
Terumo Advanced Perfusion System 1 System 1 Base, 100/120V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perf
Terminated
DTQK022947
Jul 9, 2012Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V. The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardio
Terminated
DTQK022947
Jul 9, 2012Terumo Cardiovascular Systems Corporation
System 1 Base 100/120V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop
Terminated
DTQK022947
Jul 9, 2012Terumo Cardiovascular Systems Corporation
System 1 Base 220/240V The Terumo Advanced Perfusion System 1 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiop
Terminated
DTQK022947

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