FDA 510(k) Applications for Medical Device Product Code: DXF (Catheter, Septostomy)

FDA 510(k) Applications for Medical Device Product Code "DXF"
(Catheter, Septostomy)

FDA 510(k) Number	Applicant	Device Name	Decision Date
K990284	BAYLIS MEDICAL CO., INC.	BAYLIS MEDICAL RF SEPTOSTOMY GENERATOR, NYKANEN RF SEPTOSTOMY CATHETER, BAYLIS MEDICAL CONNECTOR CABLE	02/01/2001
K073326	BAYLIS MEDICAL CO., INC.	NRG TRANSSEPTAL NEEDLE	05/28/2008
K031949	BAYLIS MEDICAL CO., INC.	TORONTO RF SEPTOSTOMY CATHETER, MODEL TSC-50-75	12/10/2003
K150709	BAYLIS MEDICAL COMPANY INC.	ProTrack RF Anchor Wire	06/17/2015
K182399	Cook Incorporated	Park Blade Septostomy Catheter	04/04/2019
K221528	Edwards Lifesciences, LLC	Fogarty Dilation Atrioseptostomy Catheter, Miller Balloon Atrioseptostomy Catheter	08/22/2022
K001804	NUMED, INC.	NUMED Z-5 ATRIOSEPTOSTOMY CATHETER	07/12/2000
K011557	NUMED, INC.	PTA, PTV, ATRIOSEPTOSTOMY, ANGIOGRAPHIC, SIZING CATHETERS	07/12/2001
K211910	NuMED, Inc.	Z-6 Atrioseptostomy Catheter	07/19/2021