TRAC-WRIGHT SYSTEM, MODEL TW2— 510(k) K910594

Substantially Equivalent

Dow Corning Wright

FDA 510(k) clearance K910594 for TRAC-WRIGHT SYSTEM, MODEL TW2, Substantially Equivalent on 1991-09-23. Applicant: Dow Corning Wright.

Clearance details

Applicant: Dow Corning Wright
Product code: Code DXT
Advisory panel: Cardiovascular
Date received: 1991-02-12
Decision date: 1991-09-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Arlington, TN, US

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Adverse events under product code DXT

product code DXT

Death: 39
Injury: 242
Malfunction: 463
Other: 3
Total: 747

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.