LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100— 510(k) K020271

Substantially Equivalent

Levitronix, LLC

FDA 510(k) clearance K020271 for LEVITRONIX CENTRIMAG EXTRACORPOREAL BLOOD PUMPING SYSTEM, MODEL L-100, Substantially Equivalent on 2003-03-25. Applicant: Levitronix, LLC.

Clearance details

Applicant: Levitronix, LLC
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2002-01-28
Decision date: 2003-03-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Waltham, MA, US

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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.