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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 K844972
Device Name ADV CARDIO SYS DBL LUMEN BALLOON DILATA CATHETER
Applicant
Advanced Cardiovascular Systems, Inc.
1500 Salado Dr., Suite 101
Mountain View,  CA  04043
Applicant Contact JANE E BEGGS
Correspondent
Advanced Cardiovascular Systems, Inc.
1500 Salado Dr., Suite 101
Mountain View,  CA  04043
Correspondent Contact JANE E BEGGS
Regulation Number870.1250
Classification Product Code
LIT  
Date Received12/24/1984
Decision Date 05/16/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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