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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 K152310
Device Name HeartLight Deflectable Sheath
Applicant
CARDIOFOCUS, INC.
500 NICKERSON ROAD
SUITE 500-200
MARLBOROUGH,  MA  01752
Applicant Contact Seema Paliwal
Correspondent
CARDIOFOCUS, INC.
500 NICKERSON ROAD
SUITE 500-200
MARLBOROUGH,  MA  01752
Correspondent Contact Seema Paliwal
Regulation Number870.1280
Classification Product Code
DRA  
Subsequent Product Code
DYB  
Date Received08/14/2015
Decision Date 02/24/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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