ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE

Temporary Carotid Catheter For Embolic Capture

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 Angioguard Xp Emboli Capture Guidewire And Angioguard Rx Emboli Capture Guidewire.

Pre-market Notification Details

Device IDK062531
510k NumberK062531
Device Name:ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
ClassificationTemporary Carotid Catheter For Embolic Capture
Applicant CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDERHORN DRIVE Warren,  NJ  07059
ContactJoan Martin
CorrespondentJoan Martin
CORDIS CORP., A JOHNSON & JOHNSON CO. 7 POWDERHORN DRIVE Warren,  NJ  07059
Product CodeNTE  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2006-08-29
Decision Date2006-09-22
Summary:summary

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