FDA 510(k) Application Details - K233357

Device Classification Name	More FDA Info for this Device
510(K) Number	K233357
Device Name	EsoCool Thermal Regulation Catheter
Applicant	Nuvaira, Inc. 6500 Wedgewood North, Suite 100 Maple Grove, MN 55311 US Other 510(k) Applications for this Company
Contact	John Carline Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/29/2023
Decision Date	06/27/2024
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review