Lifetech Cardio Temporary Pacemaker— 510(k) K232721

Name: FDA 510(k) clearance K232721
Creator: U.S. Food and Drug Administration
Published: 2024-01-07

Substantially Equivalent

Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

FDA 510(k) clearance K232721 for Lifetech Cardio Temporary Pacemaker, Substantially Equivalent on 2024-01-07. Applicant: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Product code: Code DTE
Device class: Class 2
Regulation: 21 CFR 870.3600
Advisory panel: Cardiovascular
Date received: 2023-09-05
Decision date: 2024-01-07
Decision: Substantially Equivalent
Clearance type: Special
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTE

view all

K241781 — Solo Pace Control2025-01-10
K201011 — Medtronic Model 5392 External Pulse Generator (EPG)2020-05-13
K190825 — Medtronic Model 5392 External Pulse Generator (EPG)2019-04-30
K182839 — Lifetech Cardio Model 8301 Temporary Pacemaker2019-02-28
K181973 — Medtronic Model 5392 External Pulse Generator (EPG)2018-08-21

Adverse events under product code DTE

product code DTE

Death: 18
Injury: 247
Malfunction: 4,603
Total: 4,868

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.