STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE— 510(k) K001961

Substantially Equivalent

Stoeckert Instrumente

FDA 510(k) clearance K001961 for STOCKERT A242 AND A252 SERIES ARTERIAL FEMORAL CANNULAE, Substantially Equivalent on 2001-01-25. Applicant: Stoeckert Instrumente.

Clearance details

Applicant: Stoeckert Instrumente
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 2000-06-27
Decision date: 2001-01-25
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Arvada, 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.