Cleared Special

Advisor? HD Grid X Mapping Catheter, Sensor Enabled?

K241372 · Abbott Medical · Cardiovascular
Jul 2024
Decision
55d
Days
Class 2
Risk

About This 510(k) Submission

K241372 is an FDA 510(k) clearance for the Advisor? HD Grid X Mapping Catheter, Sensor Enabled?, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Abbott Medical (Plymouth, Mn, US). The FDA issued a Cleared decision on July 9, 2024, 55 days after receiving the submission on May 15, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K241372 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 2024
Decision Date July 09, 2024
Days to Decision 55 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MTD — Catheter, Intracardiac Mapping, High-density Array
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1220

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