ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN— 510(k) K850917

Substantially Equivalent

Sherwood Medical Co.

FDA 510(k) clearance K850917 for ARGYLE GRIFFITH TDMAC HEPARINIZED VENO-VENOUS SHUN, Substantially Equivalent on 1985-05-21. Applicant: Sherwood Medical Co..

Clearance details

Applicant: Sherwood Medical Co.
Product code: Code DWF
Advisory panel: Cardiovascular
Date received: 1985-03-05
Decision date: 1985-05-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: St. Louis, MO, 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.