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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Temporary Carotid Catheter For Embolic Capture
510(k) Number K062531
Device Name ANGIOGUARD XP EMBOLI CAPTURE GUIDEWIRE AND ANGIOGUARD RX EMBOLI CAPTURE GUIDEWIRE
Applicant
Cordis Corp., A Johnson & Johnson Co.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact JOAN MARTIN
Correspondent
Cordis Corp., A Johnson & Johnson Co.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact JOAN MARTIN
Regulation Number870.1250
Classification Product Code
NTE  
Date Received08/29/2006
Decision Date 09/22/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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