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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name introducer, catheter
510(k) Number K162427
Device Name Vado Bi-Directional Steerable Sheath
Applicant
KALILA MEDICAL, INC.
745 CAMDEN AVE, SUITE A
CAMPBELL,  CA  95008 -4146
Applicant Contact CARRIE NEUBERGER
Correspondent
KALILA MEDICAL, INC.
745 CAMDEN AVE, SUITE A
CAMPBELL,  CA  95008 -4146
Correspondent Contact CARRIE NEUBERGER
Regulation Number870.1340
Classification Product Code
DYB  
Date Received08/30/2016
Decision Date 01/27/2017
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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