FDA 510(k) Application Details - K223508

Device Classification Name	Surgical Device, For Ablation Of Cardiac Tissue   More FDA Info for this Device
510(K) Number	K223508
Device Name	Surgical Device, For Ablation Of Cardiac Tissue
Applicant	Medtronic Inc. 7611 Northland Drive Minneapolis, MN 55448 US Other 510(k) Applications for this Company
Contact	Rajitha Nair Other 510(k) Applications for this Contact
Regulation Number	878.4400   More FDA Info for this Regulation Number
Classification Product Code	OCL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2022
Decision Date	12/22/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	SU - General & Plastic Surgery
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review