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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K013581
Device Name CORDIS AVIATOR PERIPHERAL DILATATION CATHETER
Applicant
Cordis, A Johnson & Johnson Co.
7 Powderhorn Dr.
Warren,  NJ  07059
Applicant Contact CHUCK RYAN
Correspondent
Cordis, A Johnson & Johnson Co.
7 Powderhorn Dr.
Warren,  NJ  07059
Correspondent Contact CHUCK RYAN
Regulation Number870.1250
Classification Product Code
DQY  
Subsequent Product Code
LIT  
Date Received10/29/2001
Decision Date 11/28/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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