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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 K252309
Device Name PerQseal Introducers
Applicant
Vivasure Medical Limited
Parkmore Business Park W.
Galway,  IE H91 V3KP
Applicant Contact Tom Maguire
Correspondent
Mcra, LLC
803 7th St. NW, 3rd Floor
Washington,  DC  20001
Correspondent Contact Fernando Aguel
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/24/2025
Decision Date 10/23/2025
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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