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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 K161659
Device Name FlexSeal Introducer Sheath with Hydrophilic Coating
Applicant
Libramedical, Inc.
8401 73rd Ave. N.
Suite 63
Minneapolis,  MN  55428
Applicant Contact SEW-WAH TAY
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1340
Classification Product Code
DYB  
Date Received06/16/2016
Decision Date 07/15/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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