EXTRACORPOREAL BLOOD GAS SYSTEM

Sensor, Blood-gas, In-line, Cardiopulmonary Bypass

CARDIOVASCULAR DEVICES, INC.

The following data is part of a premarket notification filed by Cardiovascular Devices, Inc. with the FDA for Extracorporeal Blood Gas System.

Pre-market Notification Details

Device IDK822000
510k NumberK822000
Device Name:EXTRACORPOREAL BLOOD GAS SYSTEM
ClassificationSensor, Blood-gas, In-line, Cardiopulmonary Bypass
Applicant CARDIOVASCULAR DEVICES, INC. 4221 Richmond Rd., N.W. Walker,  MI  49534
Product CodeDTY  
CFR Regulation Number870.4410 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-07-07
Decision Date1982-12-22

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