CERENOVUS Large Bore Catheter

Catheter, Percutaneous

Codman & Shurtleff, Inc.

The following data is part of a premarket notification filed by Codman & Shurtleff, Inc. with the FDA for Cerenovus Large Bore Catheter.

Pre-market Notification Details

Device IDK191237
501k NumberK191237
Device Name:CERENOVUS Large Bore Catheter
ClassificationCatheter, Percutaneous
Applicant Codman & Shurtleff, Inc. 325 Paramount Drive Raynham,  MA  02767
ContactKirsten Franco
CorrespondentKirsten Franco
Codman & Shurtleff, Inc. 325 Paramount Drive Raynham,  MA  02767
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
501k Review PanelNeurology
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-05-08
Decision Date2019-11-08

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