Cleared Traditional

Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013)

K233943 · Medtronic, Inc. · Cardiovascular
Mar 2024
Decision
85d
Days
Class 2
Risk

About This 510(k) Submission

K233943 is an FDA 510(k) clearance for the Affera Mapping System (AFR-00003); Location Reference Patch Kit (AFR-00007); System Cart (AFR-00013), 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 March 8, 2024, 85 days after receiving the submission on December 14, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K233943 FDA.gov
FDA Decision Cleared SESE
Date Received December 14, 2023
Decision Date March 08, 2024
Days to Decision 85 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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