018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter— 510(k) K180007

Substantially Equivalent

Creagh Medical, Ltd.

FDA 510(k) clearance K180007 for 018 Hydrophilic Coated OTW PTA Balloon Dilatation Catheter, Substantially Equivalent on 2018-04-19. Applicant: Creagh Medical, Ltd..

Clearance details

Applicant: Creagh Medical, Ltd.
Product code: Code LIT
Advisory panel: Cardiovascular
Date received: 2018-01-02
Decision date: 2018-04-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ballinasloe, IE

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.