EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade +1 more— 510(k) K223094

Clearance details

Device name as filed

EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software Upgrade; EnSite X EP System TactiFlex Ablation Catheter, Sensor Enabled, Software License

Applicant

ABBOTT MEDICAL

Product code

Code DQK

Device class

Class 2

Regulation

21 CFR 870.1425

Advisory panel

Cardiovascular

Date received

2022-09-30

Decision date

2022-12-27

Decision

Substantially Equivalent

Clearance type

Traditional

Location

St. Paul, MN, US

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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 →