ANGIOMAT 3000, 6000, CT INJECTOR— 510(k) K944875

Substantially Equivalent

Lievel-Flarsheim Co.

FDA 510(k) clearance K944875 for ANGIOMAT 3000, 6000, CT INJECTOR, Substantially Equivalent on 1995-01-04. Applicant: Lievel-Flarsheim Co..

Clearance details

Applicant: Lievel-Flarsheim Co.
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1994-10-03
Decision date: 1995-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Oh, OH, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.