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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Percutaneous, Cutting/Scoring
510(k) Number K202187
Device Name FLEX Vessel Prep System
Applicant
Venturemed Group, Inc.
2800 Camput Dr., Suite 50
Plymouth,  MN  55441
Applicant Contact Jill Schweiger
Correspondent
Venturemed Group, Inc.
2800 Camput Dr., Suite 50
Plymouth,  MN  55441
Correspondent Contact Jill Schweiger
Regulation Number870.1250
Classification Product Code
PNO  
Date Received08/04/2020
Decision Date 09/11/2020
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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