510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K051373Substantially Equivalent

Cronus Guidewire, Model 001-001470-1

Stereotaxis Inc, Saint Louis MO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K051373 is the FDA 510(k) clearance record for CRONUS GUIDEWIRE, MODEL 001-001470-1, a class II device, cleared for Stereotaxis, Inc. on under FDA product code NDQ (System, Catheter Or Guidewire, Steerable (Magnetic)). FDA records list 28 510(k) clearances for Stereotaxis, Inc., from to . As of , FDA records show no recalls naming K051373.

Clearance record

Decision date
Received
(197 days to decision)
Product code
NDQ System, Catheter Or Guidewire, Steerable (Magnetic)
Regulation
21 CFR 870.1290
Device class
Class II
Review panel
Cardiovascular
Applicant
Stereotaxis, Inc. 4041 Forest Park Ave., Saint Louis MO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NDQ

Trailing 12 months

FDA records hold no clearances under product code NDQ in the trailing twelve months.

FDA records show no clearances under product code NDQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code NDQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260