510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K002869Substantially Equivalent

Localisa Cardiac Navigation System

Medtronic Navigation, Inc, Shoreview MN / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K002869 is the FDA 510(k) clearance record for LOCALISA CARDIAC NAVIGATION SYSTEM, a class II device, cleared for Medtronic Surgical Navigation Technologies on under FDA product code DQK (Computer, Diagnostic, Programmable). FDA records list 85 510(k) clearances for MEDTRONIC NAVIGATION, INC., from to . As of , FDA records show no recalls naming K002869.

Clearance record

Decision date
Received
(195 days to decision)
Product code
DQK Computer, Diagnostic, Programmable
Regulation
21 CFR 870.1425
Device class
Class II
Review panel
Cardiovascular
Applicant
Medtronic Surgical Navigation Technologies 3850 Victoria St. N., Shoreview MN
510(k) summary
Summary
Third party review
No

Clearances, product code DQK

Trailing 12 months
27 clearances under product code DQK in the twelve months to November 2026, February 2026 the highest month at 5.
Show the numbers
Monthly 510(k) clearances under FDA product code DQK, trailing twelve months
MonthClearances
December 20254
January 20262
February 20265
March 20260
April 20263
May 20261
June 20263
July 20264
August 20262
September 20261
October 20262
November 20260