FDA 510(k) Application Details - K213002

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K213002
Device Name	Introducer, Catheter
Applicant	Argon Medical Devices 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	870.1340   More FDA Info for this Regulation Number
Classification Product Code	DYB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/20/2021
Decision Date	10/14/2021
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