MODIFIED HD GUIDE CATHETER

Catheter, Percutaneous

CONCENTRIC MEDICAL, INC.

The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Hd Guide Catheter.

Pre-market Notification Details

Device IDK133177
510k NumberK133177
Device Name:MODIFIED HD GUIDE CATHETER
ClassificationCatheter, Percutaneous
Applicant CONCENTRIC MEDICAL, INC. 301 EAST EVELYN AVENUE Mountain View,  CA  94041
ContactRhoda Santos
CorrespondentRhoda Santos
CONCENTRIC MEDICAL, INC. 301 EAST EVELYN AVENUE Mountain View,  CA  94041
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-17
Decision Date2014-02-25
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
07613327313987 K133177 000
07613327313963 K133177 000
07613327313949 K133177 000
07613327313932 K133177 000
07613327313925 K133177 000
07613327313918 K133177 000
07613327313901 K133177 000
07613327313895 K133177 000
07613327313888 K133177 000

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