FDA 510(k) Application Details - K250105

Device Classification Name	Valvulotome   More FDA Info for this Device
510(K) Number	K250105
Device Name	Valvulotome
Applicant	Aveera Medical, Inc. 929 Calle Negocio, Suite A San Clemente, CA 92673 US Other 510(k) Applications for this Company
Contact	Christopher Chapek Other 510(k) Applications for this Contact
Regulation Number	870.4885   More FDA Info for this Regulation Number
Classification Product Code	MGZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/15/2025
Decision Date	07/03/2025
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