VENA CAVA UMBRELLA FILTER, MODEL 7321— 510(k) K771046

Substantially Equivalent

Edwards Laboratories

FDA 510(k) clearance K771046 for VENA CAVA UMBRELLA FILTER, MODEL 7321, Substantially Equivalent on 1977-06-22. Applicant: Edwards Laboratories.

Clearance details

Applicant: Edwards Laboratories
Product code: Code DTK
Advisory panel: Cardiovascular
Date received: 1977-06-10
Decision date: 1977-06-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code DTK

product code DTK

Death: 208
Injury: 11,286
Malfunction: 3,002
Total: 14,496

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.