FDA 510(k) Application Details - K203409

Device Classification Name	More FDA Info for this Device
510(K) Number	K203409
Device Name	MC3 Crescent Jugular Dual Lumen Catheter
Applicant	MC3, Inc. 2555 Bishop Circle West Dexter, MI 48130 US Other 510(k) Applications for this Company
Contact	Martha Rumford Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PZS Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/19/2020
Decision Date	05/03/2021
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