FDA 510(k) Application Details - K250971

Device Classification Name	Device, Vascular, For Promoting Embolization   More FDA Info for this Device
510(K) Number	K250971
Device Name	Device, Vascular, For Promoting Embolization
Applicant	Biosphere Medical, S.A. Parc des Nations Paris Nord 2 383 rue de la Belle Etolle Roissy-en-France 95700 FR Other 510(k) Applications for this Company
Contact	Rosene Amosse Other 510(k) Applications for this Contact
Regulation Number	870.3300   More FDA Info for this Regulation Number
Classification Product Code	KRD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/31/2025
Decision Date	05/16/2025
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