FDA 510(k) Application Details - K243884

Device Classification Name	More FDA Info for this Device
510(K) Number	K243884
Device Name	TAVIPILOT
Applicant	Caranx Medical 12/14 Rue Jean Antoine de Baif Paris 75013 FR Other 510(k) Applications for this Company
Contact	Pierrre Berthet-Rayne 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	12/18/2024
Decision Date	07/07/2025
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