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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 K965140
Device Name CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
Applicant
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Applicant Contact ERIN DIGNAN
Correspondent
Cardio Metrics, Inc.
645 Clyde Ave.
Mountain View,  CA  94043
Correspondent Contact ERIN DIGNAN
Regulation Number870.1330
Classification Product Code
DQX  
Date Received12/23/1996
Decision Date 08/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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