STOCKERT CORONARY PERFUSION CANNULAE— 510(k) K022280

Substantially Equivalent

Stockert Instrumente GmbH

FDA 510(k) clearance K022280 for STOCKERT CORONARY PERFUSION CANNULAE, Substantially Equivalent on 2002-10-11. Applicant: Stockert Instrumente GmbH.

Clearance details

Applicant: Stockert Instrumente GmbH
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2002-07-15
Decision date: 2002-10-11
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Morrison, CO, US

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Adverse events under product code DWF

product code DWF

Death: 106
Injury: 386
Malfunction: 2,323
Total: 2,815

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.