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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 K093866
Device Name EVALVE STEERABLE GUIDE CATHETER
Applicant
EVALVE INC
4045 CAMPBELL AVENUE
MENLO PARK,  CA  94025
Applicant Contact SEVRINA CIUCCI
Correspondent
EVALVE INC
4045 CAMPBELL AVENUE
MENLO PARK,  CA  94025
Correspondent Contact SEVRINA CIUCCI
Regulation Number870.1280
Classification Product Code
DRA  
Date Received12/17/2009
Decision Date 01/13/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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