MICRO GUIDE CATHETER XP

Catheter For Crossing Total Occlusions

CORDIS CORP.

The following data is part of a premarket notification filed by Cordis Corp. with the FDA for Micro Guide Catheter Xp.

Pre-market Notification Details

Device IDK082143
510k NumberK082143
Device Name:MICRO GUIDE CATHETER XP
ClassificationCatheter For Crossing Total Occlusions
Applicant CORDIS CORP. 7 POWDER HORN DR. Warren,  NJ  07059
ContactKaren Wilk
CorrespondentKaren Wilk
CORDIS CORP. 7 POWDER HORN DR. Warren,  NJ  07059
Product CodePDU  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-30
Decision Date2008-08-25
Summary:summary

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