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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name wire, guide, catheter
510(k) Number K861765
Device Name ACS WHOLEY HI-TORQUE GUIDE WIRE
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Applicant Contact MARIANNA FAIST
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
1395 CHARLESTON RD.
MOUNTAIN VIEW,  CA  94043
Correspondent Contact MARIANNA FAIST
Regulation Number870.1330
Classification Product Code
DQX  
Date Received05/07/1986
Decision Date 05/30/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
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