FDA 510(k) Application Details - K242612

Device Classification Name	Filter, Intravascular, Cardiovascular   More FDA Info for this Device
510(K) Number	K242612
Device Name	Filter, Intravascular, Cardiovascular
Applicant	Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 US Other 510(k) Applications for this Company
Contact	Scott Bishop 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	09/03/2024
Decision Date	09/10/2024
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