FDA 510(k) Application Details - K243432

Device Classification Name	More FDA Info for this Device
510(K) Number	K243432
Device Name	Vascular Navigation PAD 2.0; Navigation Software Vascular PAD
Applicant	Brainlab AG Olof-Palme-Str.9 Munich 81829 DE Other 510(k) Applications for this Company
Contact	Sadwini Suresh Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	OWB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/05/2024
Decision Date	07/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	RA - Radiology
Review Advisory Committee	RA - Radiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review