Cleared Traditional

Affera Integrated Mapping System; Impedance Localization Patch Kit

K241828 · Medtronic, Inc. · Cardiovascular
Nov 2024
Decision
130d
Days
Class 2
Risk

About This 510(k) Submission

K241828 is an FDA 510(k) clearance for the Affera Integrated Mapping System; Impedance Localization Patch Kit, 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 November 1, 2024, 130 days after receiving the submission on June 24, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K241828 FDA.gov
FDA Decision Cleared SESE
Date Received June 24, 2024
Decision Date November 01, 2024
Days to Decision 130 days
Submission Type Traditional
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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