Lifetech Cardio Model 8301 Temporary Pacemaker— 510(k) K182839

Substantially Equivalent

Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.

FDA 510(k) clearance K182839 for Lifetech Cardio Model 8301 Temporary Pacemaker, Substantially Equivalent on 2019-02-28. Applicant: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd..

Clearance details

Applicant: Shenzhen Lifetech Cardio Medical Electronics Co., Ltd.
Product code: Code DTE
Advisory panel: Cardiovascular
Date received: 2018-10-09
Decision date: 2019-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

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.