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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Balloon Aortic Valvuloplasty
510(k) Number K241562
Device Name OutFlo Aortic Valve Dilatation Balloon Catheter
Applicant
Disa Medinotec
Stand 171, Northlands Business Park, Bush Telegraph St.
Northriding
Johannesburg,  ZA 2169
Applicant Contact Lyndon Oldfield
Correspondent
Biologics Consulting Group
100 Daingerfield Rd.
Suite 400
Alexandria,  VA  22314
Correspondent Contact Matthew Krueger
Regulation Number870.1255
Classification Product Code
OZT  
Date Received05/31/2024
Decision Date 03/11/2025
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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