FDA 510(k) Application Details - K223766

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K223766
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Biosense Webster, Inc. 31 Technology Drive, Suite 200 Irvine, CA 90618 US Other 510(k) Applications for this Company
Contact	Sheba Chacko Other 510(k) Applications for this Contact
Regulation Number	870.1200   More FDA Info for this Regulation Number
Classification Product Code	OBJ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/15/2022
Decision Date	02/16/2023
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