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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 K192313
Device Name Halo One Thin-Walled Guiding Sheath
C.R. Bard, Inc.
Moyne Upper
Enniscorthy,  IE
Applicant Contact Elizabeth Delahunty
C.R. Bard, Inc.
Moyne Upper
Enniscorthy,  IE
Correspondent Contact Elizabeth Delahunty
Regulation Number870.1340
Classification Product Code
Date Received08/26/2019
Decision Date 12/19/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No