FDA 510(k) Application Details - K241562

Device Classification Name	More FDA Info for this Device
510(K) Number	K241562
Device Name	OutFlo Aortic Valve Dilatation Balloon Catheter
Applicant	DISA Medinotec Stand 171, Northlands Business Park, Bush Telegraph Street Northriding Johannesburg 2169 ZA Other 510(k) Applications for this Company
Contact	Lyndon Oldfield Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OZT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/31/2024
Decision Date	03/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review