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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aspiration Thrombectomy Catheter
510(k) Number K250013
Device Name VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S, VS8-MP90S, VS8-MP100B, VS10-MP100B, VS11-MP60S, VS11-MP90S, VS12-MP100B, 7F-MP60S, 7F-MP90S, 8F-MP60S, 8F-MP100B, 10F-MP100B, 11F-MP60S, 11F-MP90S, 11P-MP60S, 11P-MP90S, 12F-MP100B, V30-ASP)
Applicant
Control Medical Technology, Inc. / Dba Ventiv Scientific
2757 S. 300 W. Suite F
Salt Lake City,  UT  84115
Applicant Contact Shawn Fojtik
Correspondent
Peak Regulatory Consulting
370 S. 300 E
Salt Lake City,  UT  84111
Correspondent Contact Spencer Walker
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received01/02/2025
Decision Date 03/24/2025
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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