FDA 510(k) Application Details - K213492

Device Classification Name	Introducer, Catheter   More FDA Info for this Device
510(K) Number	K213492
Device Name	Introducer, Catheter
Applicant	Dib UltraNav Medical, LLC 123 W. Mills Avenue STE 600 El Paso, TX 79901 US Other 510(k) Applications for this Company
Contact	Lowry Barfield 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	11/01/2021
Decision Date	03/24/2022
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