FDA 510(k) Application Details - K241507

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K241507
Device Name	Filter, Intravascular, Cardiovascular
Applicant	ALN S.A.R.L. 589 chemin du Niel Bormes les Mimosas 83230 FR Other 510(k) Applications for this Company
Contact	Nigon Alain Other 510(k) Applications for this Contact
Regulation Number	870.3375   More FDA Info for this Regulation Number
Classification Product Code	DTK Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/28/2024
Decision Date	06/26/2024
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