FDA 510(k) Application Details - K211662

Device Classification Name	Catheter, Mapping, Intracardiac, Reprocessed   More FDA Info for this Device
510(K) Number	K211662
Device Name	Catheter, Mapping, Intracardiac, Reprocessed
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	870.1220   More FDA Info for this Regulation Number
Classification Product Code	NLG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/01/2021
Decision Date	11/18/2021
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