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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 K954913
Device Name CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)
Applicant
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact SUSAN E OSBORNE-NORIEGA
Correspondent
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact SUSAN E OSBORNE-NORIEGA
Regulation Number870.1330
Classification Product Code
DQX  
Date Received10/03/1995
Decision Date 11/07/1995
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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