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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Device, Percutaneous Retrieval
510(k) Number K222083
Device Name LimFlow V-Ceiver
Applicant
LimFlow Inc.
3031 Tisch Way - 110 Plaza West
San Jose,  CA  95128
Applicant Contact Zachary Woodson
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number870.5150
Classification Product Code
MMX  
Date Received07/15/2022
Decision Date 08/09/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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