WILLOW/ELM PTA BALLOON DILATATION CATHETER— 510(k) K102645

Substantially Equivalent

Creagh Medical, Ltd.

FDA 510(k) clearance K102645 for WILLOW/ELM PTA BALLOON DILATATION CATHETER, Substantially Equivalent on 2010-12-10. Applicant: Creagh Medical, Ltd..

Clearance details

Applicant: Creagh Medical, Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2010-09-13
Decision date: 2010-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: North Reading, MA, 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.