FDA 510(k) Application Details - K214025

Device Classification Name	Catheter, Continuous Flush   More FDA Info for this Device
510(K) Number	K214025
Device Name	Catheter, Continuous Flush
Applicant	Medos International Sarl Chemin-Blanc 38 Le Locle 2400 CH Other 510(k) Applications for this Company
Contact	Ivenette Guzman Other 510(k) Applications for this Contact
Regulation Number	870.1210   More FDA Info for this Regulation Number
Classification Product Code	KRA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/22/2021
Decision Date	04/12/2022
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	NE - Neurology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review