510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013484Substantially Equivalent

Telstar Magnetic Navigation Systems [Mns}, Telstar Bi-Plane Digital Imaging System, Niobe Electrophysiology Mapping Cath

Stereotaxis Inc, St. Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013484 is the FDA 510(k) clearance record for TELSTAR MAGNETIC NAVIGATION SYSTEMS [MNS}, TELSTAR BI-PLANE DIGITAL IMAGING SYSTEM, NIOBE ELECTROPHYSIOLOGY MAPPING CATH, a class II device, cleared for Stereotaxis, Inc. on under FDA product code DRF (Catheter, Electrode Recording, Or Probe, Electrode Recording). FDA records list 28 510(k) clearances for Stereotaxis, Inc., from to . As of , FDA records show no recalls naming K013484.

Clearance record

Decision date
Received
(195 days to decision)
Product code
DRF Catheter, Electrode Recording, Or Probe, Electrode Recording
Regulation
21 CFR 870.1220
Device class
Class II
Review panel
Cardiovascular
Applicant
Stereotaxis, Inc. 4041 Forest Park Blvd., St. Louis MO
510(k) summary
Summary
Third party review
No

Clearances, product code DRF

Trailing 12 months
1 clearance under product code DRF in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code DRF, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260