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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 K851854
Device Name ADVANCED CARDIOVASCULAR SYS LOW PROFILE PTA BALLOO
Applicant
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Applicant Contact MARIANNA F BRESHINI
Correspondent
Advanced Cardiovascular Systems, Inc.
1395 Charleston Rd.
Mountain View,  CA  94043
Correspondent Contact MARIANNA F BRESHINI
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/26/1985
Decision Date 08/05/1985
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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