FDA 510(k) Application Details - K213584

Device Classification Name	More FDA Info for this Device
510(K) Number	K213584
Device Name	Reprocessed NRG Transseptal Needle
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	QLZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/12/2021
Decision Date	04/04/2023
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