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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter For Crossing Total Occlusions
510(k) Number K251376
Device Name LimFlow ARC
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 Number870.1250
Classification Product Code
PDU  
Date Received05/02/2025
Decision Date 05/31/2025
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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