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)
Top companies in DTQ
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2013 | Salyer 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 |
DTQ | None listed |
| Nov 27, 2012 | Terumo 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 |
DTQ | K022947 |
| Nov 27, 2012 | Terumo 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 |
DTQ | K022947 |
| Nov 13, 2012 | Terumo 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 |
DTQ | K915183 |
| Nov 13, 2012 | Terumo 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 |
DTQ | K915183 |
| Nov 13, 2012 | Terumo 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 |
DTQ | K915183 |
| Nov 13, 2012 | Terumo 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 |
DTQ | K915183 |
| Nov 13, 2012 | Terumo 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 |
DTQ | K915183 |
| Nov 13, 2012 | Terumo 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 |
DTQ | K915183 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Nov 8, 2012 | Sorin 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 |
DTQ | K071318 K093882 |
| Oct 24, 2012 | Terumo 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 |
DTQ | K915183 |
| Oct 24, 2012 | Terumo 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 |
DTQ | K915183 |
| Oct 24, 2012 | Terumo 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 |
DTQ | K915183 |
| Oct 24, 2012 | Terumo 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 |
DTQ | K915183 |
| Oct 24, 2012 | Terumo 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 |
DTQ | K915183 |
| Oct 24, 2012 | Terumo 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 |
DTQ | K915183 |
| Sep 25, 2012 | Terumo 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 |
DTQ | K022947 |
| Sep 24, 2012 | Terumo 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 |
DTQ | K022947 |
| Sep 11, 2012 | Terumo 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 |
DTQ | K915183 |
| Aug 21, 2012 | Terumo 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 |
DTQ | K022947 |
| Aug 21, 2012 | Terumo 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 |
DTQ | K022947 |
| Aug 21, 2012 | Terumo 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 |
DTQ | K022947 |
| Aug 21, 2012 | Terumo 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 |
DTQ | K022947 |
| Aug 16, 2012 | Terumo 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 |
DTQ | K915183 |
| Aug 9, 2012 | Terumo 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 |
DTQ | K022947 |
| Aug 9, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 20, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 20, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K871131 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K871131 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K871131 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K915183 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K915183 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K915183 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K915183 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K915183 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K915183 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 19, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 17, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 17, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 13, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 13, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 9, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 9, 2012 | Terumo 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 |
DTQ | K022947 |
| Jul 9, 2012 | Terumo 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 |
DTQ | K022947 |
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