K152913

Substantially Equivalent

GORE TIPS Set, GORE TIPS Sheath, GORE TIPS Needle

Applicant: Creganna Medical Aslo Business AS Cregganna Tactx Medical
Product code: DYB
Advisory panel: Cardiovascular
Date received: 2015-10-02
Decision date: 2016-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.