System, Catheter Or Guidewire, Steerable (Magnetic)

FDA product code NDQ · Class II (moderate risk) · 21 CFR 870.1290 · Cardiovascular

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K060967Niobe Magnetic Navigation System W/Navigant WorkstationNDQ · Traditional Stereotaxis, Inc.10/19/2006SE
K051373Cronus Guidewire, Model 001-001470-1NDQ · Traditional Stereotaxis, Inc.12/09/2005SE