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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Angioplasty, Peripheral, Transluminal
510(k) Number K130293
Device Name ADVANCE 18LP LOW PROFILE PTA BALLOON DILATATION CATHETER
Applicant
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Applicant Contact DAVID E CHADWICK
Correspondent
Cook, Inc.
750 Daniels Way
Bloomington,  IN  47404
Correspondent Contact DAVID E CHADWICK
Regulation Number870.1250
Classification Product Code
LIT  
Date Received02/06/2013
Decision Date 05/31/2013
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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