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NDQ — System, Catheter Or Guidewire, Steerable (Magnetic) Class II

FDA Device Classification

FDA product code NDQ covers "System, Catheter Or Guidewire, Steerable (Magnetic)", a Class II medical device regulated under 21 CFR 870.1290. Submissions are reviewed by the Cardiovascular panel. At least 2 recent 510(k) clearances have been granted under this product code.

Classification Details

Product Code
NDQ
Device Class
Class II
Regulation Number
870.1290
Submission Type
Review Panel
NE
Medical Specialty
Cardiovascular
Implant
No

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K060967stereotaxisNIOBE MAGNETIC NAVIGATION SYSTEM W/NAVIGANT WORKSTATIONOctober 19, 2006
K051373stereotaxisCRONUS GUIDEWIRE, MODEL 001-001470-1December 9, 2005

FDA data resources