MODIFIED PERIPHERAL DILATATION CATHETERS— 510(k) K875175

Substantially Equivalent

Schneider-Shilley (Usa)

FDA 510(k) clearance K875175 for MODIFIED PERIPHERAL DILATATION CATHETERS, Substantially Equivalent on 1988-07-28. Applicant: Schneider-Shilley (Usa).

Clearance details

Applicant: Schneider-Shilley (Usa)
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1987-12-17
Decision date: 1988-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

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Adverse events under product code LIT

product code LIT

Death: 27
Injury: 1,256
Malfunction: 12,127
Total: 13,410

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.