Ablamap Software— 510(k) K203084

Name: FDA 510(k) clearance K203084
Creator: U.S. Food and Drug Administration
Published: 2021-08-31

Substantially Equivalent

Ablacon, Inc.

FDA 510(k) clearance K203084 for Ablamap Software, Substantially Equivalent on 2021-08-31. Applicant: Ablacon, Inc.. Device class: 2.

Clearance details

Applicant: Ablacon, Inc.
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2020-10-13
Decision date: 2021-08-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Denver, CO, US

Download summary PDF View on FDA.gov ↗

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K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

More clearances from Ablacon, Inc.

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K230008 — Ablamap® System2023-06-08
K223666 — Ablacath Mapping Catheter2023-03-17

Adverse events under product code DQK

product code DQK

Death: 10
Injury: 225
Malfunction: 2,123
Other: 2
Total: 2,360

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.