FDA 510(k) Application Details - K221528

Device Classification Name	Catheter, Septostomy   More FDA Info for this Device
510(K) Number	K221528
Device Name	Catheter, Septostomy
Applicant	Edwards Lifesciences, LLC 1 Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Mahvish Iqbal Other 510(k) Applications for this Contact
Regulation Number	870.5175   More FDA Info for this Regulation Number
Classification Product Code	DXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/26/2022
Decision Date	08/22/2022
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