CORONARY PRESSURE PERFUSION PUMP

Gauge, Pressure, Coronary, Cardiopulmonary Bypass

3M HEALTH CARE, SARNS

The following data is part of a premarket notification filed by 3m Health Care, Sarns with the FDA for Coronary Pressure Perfusion Pump.

Pre-market Notification Details

Device IDK771764
510k NumberK771764
Device Name:CORONARY PRESSURE PERFUSION PUMP
ClassificationGauge, Pressure, Coronary, Cardiopulmonary Bypass
Applicant 3M HEALTH CARE, SARNS 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDXS  
CFR Regulation Number870.4310 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1977-09-19
Decision Date1977-09-30

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