510(k) K060967

Device: NIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATION
Applicant: STEREOTAXIS, INC.
510(k) number: K060967
Product code: NDQ
Decision: Substantially Equivalent (SESE)
Decision date: 2006-10-19
Date received: 2006-04-07
Regulation: 870.1290
Classification name: System, Catheter Or Guidewire, Steerable (magnetic)
Medical specialty: Cardiovascular
Review panel: Neurology
Device class: 2
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: DENNIS POZZO
Address: 4320 Forest Park Ave., Suite 100 St. Louis MO US 63108 63108

FDA Registration Numbers#

3003084417

Source Documents#

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
M588020004500260	Navigant	Stereotaxis, Inc.	2016-10-27
M588020004500220	Navigant	Stereotaxis, Inc.	2016-08-01
M588020004500210	Navigant	Stereotaxis, Inc.	2016-08-01
M58800100610010	Niobe MNS Philips	Stereotaxis, Inc.	2016-08-01
M58800100600010	Niobe MNS Siemens	Stereotaxis, Inc.	2016-08-01
M58800100591011	Niobe Cover Drape	Stereotaxis, Inc.	2016-08-01

Other 510(k) Records For Product Code NDQ #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K051373	CRONUS GUIDEWIRE, MODEL 001-001470-1	Stereotaxis, Inc.	2005-12-09

Legacy Summary#

summary

FDA Review#

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