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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 K861847
Device Name ACS ROTATING HEMO VALVE - DUAL ACCESS TYPE
Applicant
Advanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Applicant Contact KEVIN CORRIGAN
Correspondent
Advanced Cardiovascular Systems, Inc.
26531 Ynez Rd.
Temecula,  CA  92591
Correspondent Contact KEVIN CORRIGAN
Regulation Number870.5100
Classification Product Code
LOX  
Date Received05/13/1986
Decision Date 06/16/1986
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
Recalls CDRH Recalls
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