Cleared Traditional

Ablamap? System

K230008 · Ablacon, Inc. · Cardiovascular
Jun 2023
Decision
156d
Days
Class 2
Risk

About This 510(k) Submission

K230008 is an FDA 510(k) clearance for the Ablamap? System, a Computer, Diagnostic, Programmable (Class II — Special Controls, product code DQK), submitted by Ablacon, Inc. (Denver, US). The FDA issued a Cleared decision on June 8, 2023, 156 days after receiving the submission on January 3, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1425.

Submission Details

510(k) Number K230008 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 2023
Decision Date June 08, 2023
Days to Decision 156 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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