LIFEBRIDGE— 510(k) K103357

Substantially Equivalent

Lifebridge Medizintechnik AG

FDA 510(k) clearance K103357 for LIFEBRIDGE, Substantially Equivalent on 2010-12-27. Applicant: Lifebridge Medizintechnik AG.

Clearance details

Applicant: Lifebridge Medizintechnik AG
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2010-11-16
Decision date: 2010-12-27
Decision: Substantially Equivalent
Clearance type: Special
Location: Bryn Mawr, PA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code KFM

product code KFM

Death: 109
Injury: 241
Malfunction: 1,779
Total: 2,129

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.