MICRO GUIDE CATHETER ELITE

Catheter For Crossing Total Occlusions

CORDIS CORP., A JOHNSON & JOHNSON CO.

The following data is part of a premarket notification filed by Cordis Corp., A Johnson & Johnson Co. with the FDA for Micro Guide Catheter Elite.

Pre-market Notification Details

Device IDK140438
510k NumberK140438
Device Name:MICRO GUIDE CATHETER ELITE
ClassificationCatheter For Crossing Total Occlusions
Applicant CORDIS CORP., A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PKWY. Fremont,  CA  94555
ContactMichelle Ragozzine Rodgers
CorrespondentMichelle Ragozzine Rodgers
CORDIS CORP., A JOHNSON & JOHNSON CO. 6500 PASEO PADRE PKWY. Fremont,  CA  94555
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-02-21
Decision Date2014-11-14
Summary:summary

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