CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

VITALCOR, INC.

The following data is part of a premarket notification filed by Vitalcor, Inc. with the FDA for Coronary Artery Perfusion Cannula With Self-inflating Balloon.

Pre-market Notification Details

Device IDK030231
510k NumberK030231
Device Name:CORONARY ARTERY PERFUSION CANNULA WITH SELF-INFLATING BALLOON
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant VITALCOR, INC. 100 EAST CHESTNUT AVE. Westmont,  IL  60559
ContactWilliam Huck
CorrespondentWilliam Huck
VITALCOR, INC. 100 EAST CHESTNUT AVE. Westmont,  IL  60559
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-22
Decision Date2003-04-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10851321006090 K030231 000
10851321006014 K030231 000
10851321006021 K030231 000
10851321006038 K030231 000
10851321006045 K030231 000
10851321006052 K030231 000
10851321006069 K030231 000
10851321006076 K030231 000
10851321006083 K030231 000
10851321006007 K030231 000

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