FDA 510(k) Applications for Medical Device Product Code: OTK ()

FDA 510(k) Applications for Medical Device Product Code "OTK"

FDA 510(k) Number	Applicant	Device Name	Decision Date
K093565	CLEAR CATHETER SYSTEMS	PLEURAFLOW CATHETER SYSTEM	12/03/2010
K203394	ClearFlow, Inc,	PleuraFlow System with FlowGlide	03/02/2021
K150042	ClearFlow, Inc.	PleuraFlow System	06/02/2015
K153681	CLEARFLOW, INC.	PleuraFlow System	01/20/2016
K163139	CLEARFLOW, INC.	PleuraFlow System with FlowGlide	11/30/2016
K182067	ClearFlow, Inc.	PleuraFlow System with FlowGlide Extra Drainage Length	08/14/2018
K191733	ClearFlow, Inc.	The ZIP Accessory Shuttle for PleuraFlow System	07/26/2019