FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS— 510(k) K984586

Substantially Equivalent

Fresenius Hemotechnology, Inc.

FDA 510(k) clearance K984586 for FRESENIUS ATR40 AND ATR120 AUTOTRANSFUSION RESERVOIRS, Substantially Equivalent on 1999-06-29. Applicant: Fresenius Hemotechnology, Inc..

Clearance details

Applicant: Fresenius Hemotechnology, Inc.
Product code: Code DTN
Advisory panel: Cardiovascular
Date received: 1998-12-24
Decision date: 1999-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Concord, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code DTN

product code DTN

Death: 3
Total: 3

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.