FDA 510(k) Application Details - K244046

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K244046
Device Name	Introducer, Catheter
Applicant	Edwards Lifesciences One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Andrea Gasca 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	12/30/2024
Decision Date	03/27/2025
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