Cleared Traditional

Ablacath? Mapping Catheter

K223666 · Ablacon, Inc. · Cardiovascular
Mar 2023
Decision
100d
Days
Class 2
Risk

About This 510(k) Submission

K223666 is an FDA 510(k) clearance for the Ablacath? Mapping Catheter, a Catheter, Intracardiac Mapping, High-density Array (Class II — Special Controls, product code MTD), submitted by Ablacon, Inc. (Denver, US). The FDA issued a Cleared decision on March 17, 2023, 100 days after receiving the submission on December 7, 2022. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.

Submission Details

510(k) Number K223666 FDA.gov
FDA Decision Cleared SESE
Date Received December 07, 2022
Decision Date March 17, 2023
Days to Decision 100 days
Submission Type Traditional
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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