JOSTRA MECC SYSTEM— 510(k) K023132

Substantially Equivalent

Jostra AG

FDA 510(k) clearance K023132 for JOSTRA MECC SYSTEM, Substantially Equivalent on 2002-12-17. Applicant: Jostra AG.

Clearance details

Applicant: Jostra AG
Product code: Code KFM
Advisory panel: Cardiovascular
Date received: 2002-09-20
Decision date: 2002-12-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: The Woodlands, TX, 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.