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Panels › Cardiovascular › Product code DTY · Class 2

Sensor, Blood-Gas, In-Line, Cardiopulmonary Bypass

Regulation 870.4410

0510(k)s in 12 months (8 all time)

0recalls in 12 months (2 all time)

2recalls that name a 510(k)

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Top companies in DTY

Company	510(k)s	Recalls
Cardiovascular Devices, Inc.	3	0
Terumo Cardiovascular Systems Corporation	0	2
3M Health Care, Ltd.	1	0
Cardio Metrics, Inc.	1	0
International Biophysics Corp.	1	0
Medtronic, Inc.	1	0
Medtronic Bio-Medicus, Inc.	1	0

Date	Firm and product	Code	Linked 510(k)
Apr 11, 2011	Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems Corporations, CDI 100 Hematocrit/ Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. Terminated	DTY	K902654
Apr 11, 2011	Terumo Cardiovascular Systems Corporation Terumo Cardiovascular Systems Corporations, CDI 101 Hematocrit/Oxygen Saturation Monitoring System. In-line blood-gas sensor used in cardiopulmonary bypass. Terminated	DTY	K902654

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