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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Mechanical Thrombolysis Catheter
510(k) Number K241851
Device Name Versus™ Catheter (VS110-8B)
Applicant
Liquet Medical, Inc.
5619 Country Hills Ln
Glen Allen,  VA  23059
Applicant Contact John Schindler
Correspondent
Evergreen Strategic Consulting
108 N Rolling Rd.
Catonsville,  MD  21228
Correspondent Contact Carrie Kuehn
Regulation Number870.5150
Classification Product Code
QEY  
Subsequent Product Codes
DQO   DYG   KRA  
Date Received06/27/2024
Decision Date 11/25/2024
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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