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Panels › Cardiovascular › Product code DWB · Class 2

Pump, Blood, Cardiopulmonary Bypass, Roller Type

Regulation 870.4370

0510(k)s in 12 months (21 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

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Top companies in DWB

Company	510(k)s	Recalls
Terumo Cardiovascular Systems Corp.	3	2
3M Health Care, Sarns	3	0
Shiley, Inc.	3	0
Stoeckert Instrumente	3	0
3M Health Care, Ltd.	1	0
Advocacy International, Ltd.	1	0
Angiomed U.S., Inc.	1	0
Cobe Cardiovascular, Inc.	1	0
Cobe Laboratories, Inc.	1	0
Electromedics, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Nov 29, 2011	Terumo Cardiovascular Systems Corporation Battery Module for Sarns Modular Perfusion System 8000 Product Usage: The Sarns Modular Perfusion System 8000 is indicated for up to 6 hours use in extracorporeal circulation of blood for arterial Terminated	DWB	K915183
Sep 15, 2011	Terumo Cardiovascular Systems Corporation Sarns 8000 Cardioplegia Monitor, Catalog Number 16414; also known as PROG COMP BD AMPRO 420 CPG 8K, Catalog Number 816373 The Sarns 8000 Cardioplegia Monitor is indicated to measure extracorporeal li Terminated	DWB	K960916

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