SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH— 510(k) K912317

Substantially Equivalent

Schneider Intl., Ltd.

FDA 510(k) clearance K912317 for SCHNEIDER MONORAIL 421 PERCU TRANS ANGIO PTA CATH, Substantially Equivalent on 1991-08-22. Applicant: Schneider Intl., Ltd..

Clearance details

Applicant: Schneider Intl., Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 1991-05-24
Decision date: 1991-08-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plymouth, 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.