FDA 510(k) Application Details - K183413

Device Classification Name	Transducer, Pressure, Catheter Tip   More FDA Info for this Device
510(K) Number	K183413
Device Name	Transducer, Pressure, Catheter Tip
Applicant	Edwards Lifeciences, LLC One Edwards Way Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Ye Seul Kim Other 510(k) Applications for this Contact
Regulation Number	870.2870   More FDA Info for this Regulation Number
Classification Product Code	DXO Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/10/2018
Decision Date	05/01/2019
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