EMBOLECTOMY CATHETER

Catheter, Embolectomy

CLINCAL INSTRUMENTS CORP.

The following data is part of a premarket notification filed by Clincal Instruments Corp. with the FDA for Embolectomy Catheter.

Pre-market Notification Details

Device IDK902327
510k NumberK902327
Device Name:EMBOLECTOMY CATHETER
ClassificationCatheter, Embolectomy
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 CodeDXE  
CFR Regulation Number870.5150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-05-24
Decision Date1991-02-25

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