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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dilator, Vessel, For Percutaneous Catheterization
510(k) Number K201288
Device Name ExpanSure Large Access Transseptal Dilator
Applicant
Baylis Medical Company, Inc.
2580 Matheson Blvd. E.
Mississauga,  CA L4W 4J1
Applicant Contact May Tsai
Correspondent
Baylis Medical Company, Inc.
2580 Matheson Blvd. E.
Mississauga,  CA L4W 4J1
Correspondent Contact May Tsai
Regulation Number870.1310
Classification Product Code
DRE  
Date Received05/14/2020
Decision Date 06/12/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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