EnSite Velocity Cardiac Mapping System v5.2, EnSite Precision Cardiac Mapping System v2.2— 510(k) K183128

Clearance details

Applicant

Abbott

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2018-11-13

Decision date

2018-12-12

Decision

Substantially Equivalent

Clearance type

Special

Location

St. Paul, MN, US

• 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

• K261825 — Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP Catheter2026-07-02
• K260993 — Amplatzer TorqVue Delivery System2026-04-24
• 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

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 →