St Jude Medical

FDA 510(k) & PMA Approved Devices — 95 products

Total Devices95

Categories0

Latest FDA decision

Type	Number	Device Name	Code	Date	Actions
510(k)	K181382	GuardianTM Burr Hole Cover System	GXR	2018-07-20	View
510(k)	K172396	EnSite Velocity Cardiac Mapping System v5.2	DQK	2018-04-23	View
510(k)	K173232	myMerlin(TM) Mobile Application Model APP1001	MXC	2017-11-02	View
510(k)	K160210	EnSite Precision Cardiac Mapping System v2.0	DQK	2016-12-13	View
510(k)	K160335	Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D	DRF	2016-12-13	View
510(k)	K162643	MediGuide Technology System	DQK	2016-12-13	View
510(k)	K160218	AutoMark Module	DQK	2016-12-13	View
510(k)	K161873	Pacel Flow Directed Pacing Catheter	LDF	2016-11-22	View
510(k)	K160187	Ensite Velocity Cardiac Mapping System v5.0, Ensite Automap Module v1.0	DQK	2016-10-21	View
510(k)	K160186	EnSite Velocity Surface Electrode Kit	DQK	2016-10-07	View
510(k)	K152342	Guardian Burr Hole Cover System, Guardian Screw, Burr Hole Cover	GXR	2016-06-09	View
510(k)	K132073	EP-WORKMATE, EP-NURSEMATE, EP-NURSEMATE WITH PHYSIO MODULE	DQK	2013-09-09	View
510(k)	K130727	ENSITE VELOCITY SYSTEM	DQK	2013-08-29	View
510(k)	K131063	AMPLATZER TORQ VUE LP DELIVERY SYSTEM	DQY	2013-08-15	View
510(k)	K130545	MULTI LEAD TRIAL CABLE	GZB	2013-06-18	View
510(k)	K130594	ENSITE VELOCITY SYSTEM	DQK	2013-05-03	View
510(k)	K130257	CPS DIRECT UNIVERSAL SLITTABLE OUTER CATHETER	DQY	2013-03-20	View
510(k)	K130252	CPS AIM UNIVERSAL SLITTABLE INNER CATHETER	DQY	2013-03-20	View
510(k)	K122587	BRK TRANSSEPTAL NEEDLE MODEL 407200, 407201, 407205, 407206, 407207, G407208	DRC	2013-02-07	View
510(k)	K122161	SJM CONFIRM	MXC	2012-11-28	View