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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name catheter, steerable
510(k) Number K083793
Device Name STEERABLE GUIDE CATHETER
Applicant
EVALVE INC
4045 CAMPBELL AVENUE
MENLO PARK,  CA  94025
Applicant Contact KARUNA VELUSAMY
Correspondent
EVALVE INC
4045 CAMPBELL AVENUE
MENLO PARK,  CA  94025
Correspondent Contact KARUNA VELUSAMY
Regulation Number870.1280
Classification Product Code
DRA  
Date Received12/22/2008
Decision Date 04/27/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT00209274
NCT00209339
Reviewed by Third Party No
Combination Product No
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