Cleared Special

Affera Integrated Mapping System

K243892 · Medtronic, Inc. · Cardiovascular
Jan 2025
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K243892 is an FDA 510(k) clearance for the Affera Integrated Mapping System, 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 January 17, 2025, 30 days after receiving the submission on December 18, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K243892 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 2024
Decision Date January 17, 2025
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

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