FDA 510(k) Application Details - K243642

Device Classification Name	Marker, Radiographic, Implantable   More FDA Info for this Device
510(K) Number	K243642
Device Name	Marker, Radiographic, Implantable
Applicant	Bard Peripheral Vascular, Inc. 1625 West 3rd Street Tempe, AZ 85281 US Other 510(k) Applications for this Company
Contact	Meghan McKelvey Other 510(k) Applications for this Contact
Regulation Number	878.4300   More FDA Info for this Regulation Number
Classification Product Code	NEU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/26/2024
Decision Date	03/24/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review