CORONARY INFUSION KIT

Catheter, Intravascular, Diagnostic

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Coronary Infusion Kit.

Pre-market Notification Details

Device IDK822640
510k NumberK822640
Device Name:CORONARY INFUSION KIT
ClassificationCatheter, Intravascular, Diagnostic
Applicant MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-09-01
Decision Date1982-09-28

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