FDA 510(k) Application Details - K221390

Device Classification Name	Wire, Guide, Catheter   More FDA Info for this Device
510(K) Number	K221390
Device Name	Wire, Guide, Catheter
Applicant	Biomerics NLE 10351 Xylon Ave N., Suite 100 Brooklyn Park, MN 55445 US Other 510(k) Applications for this Company
Contact	Jason Albers Other 510(k) Applications for this Contact
Regulation Number	870.1330   More FDA Info for this Regulation Number
Classification Product Code	DQX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	05/13/2022
Decision Date	04/28/2023
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