FDA 510(k) Application Details - K200963

Device Classification Name	Device, Percutaneous Retrieval   More FDA Info for this Device
510(K) Number	K200963
Device Name	Device, Percutaneous Retrieval
Applicant	Argon Medical Devices, Inc. 1445 Flat Creek Road Athens, TX 75751 US Other 510(k) Applications for this Company
Contact	Ana Jimenez-Hughes Other 510(k) Applications for this Contact
Regulation Number	870.5150   More FDA Info for this Regulation Number
Classification Product Code	MMX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/10/2020
Decision Date	01/05/2021
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