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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous
510(k) Number K953987
Device Name ACS TOURGIDE GUIDING CATHETER
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Applicant Contact MARIANNE C DRENNAN
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052
Correspondent Contact MARIANNE C DRENNAN
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/23/1995
Decision Date 12/07/1995
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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