FDA 510(k) Application Details - K201652

Device Classification Name	Catheter, Intravascular Occluding, Temporary   More FDA Info for this Device
510(K) Number	K201652
Device Name	Catheter, Intravascular Occluding, Temporary
Applicant	Front Line Medical Technologies, Inc. 184 Paul Street, Unit 1 London n6hil2 CA Other 510(k) Applications for this Company
Contact	Asha Parekh Other 510(k) Applications for this Contact
Regulation Number	870.4450   More FDA Info for this Regulation Number
Classification Product Code	MJN Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	06/18/2020
Decision Date	02/22/2021
Decision	SESK - SUBST EQUIV - KIT
Classification Advisory Committee	CV - Cardiovascular
Review Advisory Committee	CV - Cardiovascular
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review