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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheters, Transluminal Coronary Angioplasty, Percutaneous
510(k) Number K843944
Device Name PTCA BALLOON CATHETERS & ACCESSORIES
Applicant
Advanced Cardiovascular Systems, Inc.
1500 Salado Dr., Suite 101
Mountain View,  CA  04043
Applicant Contact EARLE L CANTY
Correspondent
Advanced Cardiovascular Systems, Inc.
1500 Salado Dr., Suite 101
Mountain View,  CA  04043
Correspondent Contact EARLE L CANTY
Regulation Number870.5100
Classification Product Code
LOX  
Date Received10/09/1984
Decision Date 02/14/1985
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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