SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI— 510(k) K931577

Substantially Equivalent

Schneider Intl., Ltd.

FDA 510(k) clearance K931577 for SCHNEIDER MAGNUM PERIPHERAL RECANALIZATION GUIDEWI, Substantially Equivalent on 1993-06-23. Applicant: Schneider Intl., Ltd..

Clearance details

Applicant: Schneider Intl., Ltd.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1993-03-30
Decision date: 1993-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, MN, US

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Adverse events under product code DQX

product code DQX

Death: 298
Injury: 4,385
Malfunction: 7,203
Other: 5
Total: 11,891

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.