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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Clamp, Vascular
510(k) Number K190351
Device Name Site Seal SV
Applicant
Ensite Vascular
10900 S. Clay Blair Blvd., Suite 800
Olathe,  KS  66061
Applicant Contact Thomas Reidy
Correspondent
TAMM Net, Inc.
2600 Mullinix Rd.
Mt. Airy,  MD  21771
Correspondent Contact F. Blix Winston
Regulation Number870.4450
Classification Product Code
DXC  
Date Received02/14/2019
Decision Date 07/02/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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