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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 K231227
Device Name SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath
Applicant
Baylis Medical Company Inc.
5825 Explorer Dr.
Mississauga,  CA L4W 5P6
Applicant Contact Shilpa Sharma
Correspondent
Baylis Medical Company Inc.
5825 Explorer Dr.
Mississauga,  CA L4W 5P6
Correspondent Contact Shilpa Sharma
Regulation Number870.1340
Classification Product Code
DYB  
Date Received04/28/2023
Decision Date 12/20/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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