EnSite X EP System— 510(k) K221213

Name: FDA 510(k) clearance K221213
Creator: U.S. Food and Drug Administration
Published: 2022-08-18

Substantially Equivalent

Abbott

FDA 510(k) clearance K221213 for EnSite X EP System, Substantially Equivalent on 2022-08-18. Applicant: Abbott. Device class: 2.

Clearance details

Applicant: Abbott
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2022-04-27
Decision date: 2022-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

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K253692 — AVVIGO+ Multi-Modality Guidance System2026-08-21
K262005 — Affera Integrated Mapping System2026-08-21
K253576 — CorVista System® with PCWP Add-On2026-07-26
K262006 — EnSite X EP System2026-07-15
K252978 — ScioCardio ECG Analysis Platform2026-07-09

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K251221 — Assert-IQ (DM5000); Assert-IQ (DM5300); Assert-IQ (DM5500); Merlin.net (MN7000)2025-09-17
K233655 — Lingo Glucose System2024-05-29
K222297 — CentriMag Pre-connected Pack2022-12-01

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.