FDA 510(k) Application Details - K193466

Device Classification Name	Catheter, Flow Directed   More FDA Info for this Device
510(K) Number	K193466
Device Name	Catheter, Flow Directed
Applicant	Edwards Lifesciences, LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Anne Lo Other 510(k) Applications for this Contact
Regulation Number	870.1240   More FDA Info for this Regulation Number
Classification Product Code	DYG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/16/2019
Decision Date	02/16/2020
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