SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER— 510(k) K881197

Substantially Equivalent

Schneider-Shilley (Usa)

FDA 510(k) clearance K881197 for SOFTRAC-PTA(TM) PERIPHERAL DILATATION CATHETER, Substantially Equivalent on 1988-05-16. Applicant: Schneider-Shilley (Usa).

Clearance details

Applicant: Schneider-Shilley (Usa)
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1988-03-21
Decision date: 1988-05-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Minneapolis, MN, US

Download summary PDF View on FDA.gov ↗

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.