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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 K874776
Device Name ACS 0.025-IN HI-TORQ MODIF J/STAND TELESC GUIDEWIR
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 Received11/19/1987
Decision Date 02/17/1988
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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