Vyntus Walk— 510(k) K142959

Substantially Equivalent

Carefusion Germany 234 GmbH

FDA 510(k) clearance K142959 for Vyntus Walk, Substantially Equivalent on 2015-03-20. Applicant: Carefusion Germany 234 GmbH.

Clearance details

Applicant: Carefusion Germany 234 GmbH
Product code: Code DQA
Advisory panel: Cardiovascular
Date received: 2014-10-14
Decision date: 2015-03-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hoechber, DE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQA

product code DQA

Death: 66
Malfunction: 2,867
Other: 1
Total: 2,934

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.