STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

STOCKERT INSTRUMENTE GMBH

The following data is part of a premarket notification filed by Stockert Instrumente Gmbh with the FDA for Stockert Pediatric Aortic Cannulae, Model Numbers A272-15 Through A272-35.

Pre-market Notification Details

Device IDK023622
510k NumberK023622
Device Name:STOCKERT PEDIATRIC AORTIC CANNULAE, MODEL NUMBERS A272-15 THROUGH A272-35
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant STOCKERT INSTRUMENTE GMBH 20193 GOINS DR. Morrison,  CO  80465
ContactLynne Leonard
CorrespondentLynne Leonard
STOCKERT INSTRUMENTE GMBH 20193 GOINS DR. Morrison,  CO  80465
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeAbbreviated
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-10-29
Decision Date2002-11-21
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
38033178004627 K023622 000
38033178004610 K023622 000
38033178004603 K023622 000
38033178004597 K023622 000
38033178004580 K023622 000

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