CAROTID BYPASS SHUNT

Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass

CLINCAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Carotid Bypass Shunt.

Pre-market Notification Details

Device IDK860742
510k NumberK860742
Device Name:CAROTID BYPASS SHUNT
ClassificationCatheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
Applicant CLINCAL INSTRUMENTS CORP. 9 CROSS ST. Dudley,  MA  01570
ContactMichael L Polanyi
CorrespondentMichael L Polanyi
CLINCAL INSTRUMENTS CORP. 9 CROSS ST. Dudley,  MA  01570
Product CodeDWF  
CFR Regulation Number870.4210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-27
Decision Date1986-05-28

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