FDA 510(k) Application Details - K230376

Device Classification Name	More FDA Info for this Device
510(K) Number	K230376
Device Name	Reprocessed Agilis NxT Steerable Introducer
Applicant	Innovative Health, LLC. 1435 North Hayden Road, Suite 100 Scottsdale, AZ 85257 US Other 510(k) Applications for this Company
Contact	Rick Ferreira Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PNE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/13/2023
Decision Date	08/07/2023
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