FDA 510(k) Application Details - K241540

Device Classification Name	Catheter, Ultrasound, Intravascular   More FDA Info for this Device
510(K) Number	K241540
Device Name	Catheter, Ultrasound, Intravascular
Applicant	Biosense Webster, Inc. (Part of Johnson&Johnson family of Companies) 31 Technology Drive, Suite 200 Irvine, CA 92618 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	05/31/2024
Decision Date	06/28/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review