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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valvulotome
510(k) Number K260188
Device Name LimFlow Vector
Applicant
LimFlow, Inc.
6001 Oak Canyon
Suite 100
Irvine,  CA  92618
Applicant Contact Haley Ritchie
Correspondent
LimFlow, Inc.
6001 Oak Canyon
Suite 100
Irvine,  CA  92618
Correspondent Contact Haley Ritchie
Regulation Number870.4885
Classification Product Code
MGZ  
Date Received01/22/2026
Decision Date 03/18/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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