CARDIAC CATHETERIZATION KIT

Catheter, Intravascular, Diagnostic

ABBOTT LABORATORIES

The following data is part of a premarket notification filed by Abbott Laboratories with the FDA for Cardiac Catheterization Kit.

Pre-market Notification Details

Device IDK932141
510k NumberK932141
Device Name:CARDIAC CATHETERIZATION KIT
ClassificationCatheter, Intravascular, Diagnostic
Applicant ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
ContactFrederick Gustafson
CorrespondentFrederick Gustafson
ABBOTT LABORATORIES ONE ABBOTT PARK RD. Abbott Park,  IL  60064 -3500
Product CodeDQO  
CFR Regulation Number870.1200 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1993-04-22
Decision Date1994-09-22

NIH GUDID Devices

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