MODIFIED TREVO PROVUE RETRIEVER

Catheter, Thrombus Retriever

CONCENTRIC MEDICAL, INC.

The following data is part of a premarket notification filed by Concentric Medical, Inc. with the FDA for Modified Trevo Provue Retriever.

Pre-market Notification Details

Device IDK132641
510k NumberK132641
Device Name:MODIFIED TREVO PROVUE RETRIEVER
ClassificationCatheter, Thrombus Retriever
Applicant CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View,  CA  94041
ContactSarah Meyer
CorrespondentSarah Meyer
CONCENTRIC MEDICAL, INC. 301 E. EVELYN AVE. Mountain View,  CA  94041
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-08-26
Decision Date2014-01-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00815742001839 K132641 000
00815742001822 K132641 000

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