FDA 510(k) Application Details - K243928

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K243928
Device Name	Introducer, Catheter
Applicant	CardioVia Ltd. Wadi El Haj, 13, P.O. Box 1252 Nazareth 17111 IL Other 510(k) Applications for this Company
Contact	Orly Maor Other 510(k) Applications for this Contact
Regulation Number	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/20/2024
Decision Date	03/20/2025
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