Cleared Special

Magnetic Localization Patch Kit (AFR-00021)

K243435 · Medtronic, Inc. · Cardiovascular
Dec 2024
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243435 is an FDA 510(k) clearance for the Magnetic Localization Patch Kit (AFR-00021), a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Medtronic, Inc. (Mounds View, US). The FDA issued a Cleared decision on December 5, 2024, 30 days after receiving the submission on November 5, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K243435 FDA.gov
FDA Decision Cleared SESE
Date Received November 05, 2024
Decision Date December 05, 2024
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQK — Computer, Diagnostic, Programmable
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1425

Similar Devices — DQK Computer, Diagnostic, Programmable

All 423
HemoSphere Nano Monitor (HSNANO1)
K253186 · Edwards Lifesciences, LLC · Feb 2026
CARTO? 3 EP Navigation System V8.4
K252972 · Biosense Webster, Inc. · Feb 2026
IOPS Visionary System (MC-3); IOPS Viewpoint Simple Curve Catheter, 75cm (C00751); IOPS Viewpoint Simple Curve Catheter, 125cm (C01251); IOPS Viewpoint Double Curve Catheter, 75cm (C00752); IOPS Viewpoint Double Curve Catheter, 125cm (C02152); IOPS Guidewire 2 (ATW-2); IOPS Fiducial Tracking Pad (T02111); IOPS Guidewire Handle (H01035)
K254089 · Centerline Biomedical, Inc. · Feb 2026
Holter ECG and ABP system (HolterABP)
K251591 · Edan Instruments, Inc. · Feb 2026
SafeBeat Rx App
K251218 · Safebeat Rx, Inc. · Feb 2026
NorthStar? Mapping System
K252164 · Imricor Medical Systems · Jan 2026