FDA 510(k) Application Details - K240578

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K240578
Device Name	Filter, Intravascular, Cardiovascular
Applicant	B. Braun Medical Inc. 3773 Corporate Parkway Center Valley, PA 18034 US Other 510(k) Applications for this Company
Contact	Tracy Larish 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	03/01/2024
Decision Date	07/31/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review