ENSITE VELOCITY SYSTEM— 510(k) K110549

Name: FDA 510(k) clearance K110549
Creator: U.S. Food and Drug Administration
Published: 2011-05-05

Substantially Equivalent

St Jude Medical

FDA 510(k) clearance K110549 for ENSITE VELOCITY SYSTEM, Substantially Equivalent on 2011-05-05. Applicant: St Jude Medical. Device class: 2.

Clearance details

Applicant: St Jude Medical
Product code: Code DQK
Device class: Class 2
Regulation: 21 CFR 870.1425
Advisory panel: Cardiovascular
Date received: 2011-02-25
Decision date: 2011-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Paul, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DQK

view all

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

More clearances from St Jude Medical

view all

K181382 — GuardianTM Burr Hole Cover System2018-07-20
K172396 — EnSite Velocity Cardiac Mapping System v5.22018-04-23
K173232 — myMerlin(TM) Mobile Application Model APP10012017-11-02
K160210 — EnSite Precision Cardiac Mapping System v2.02016-12-13
K160218 — AutoMark Module2016-12-13

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.