Attain Assist CS Access Catheter— 510(k) K171819

Substantially Equivalent

Creganna Medical Also Doing Business AS Ceganna Tactx Medica

FDA 510(k) clearance K171819 for Attain Assist CS Access Catheter, Substantially Equivalent on 2018-01-04. Applicant: Creganna Medical Also Doing Business AS Ceganna Tactx Medica.

Clearance details

Applicant: Creganna Medical Also Doing Business AS Ceganna Tactx Medica
Product code: Code DQY
Advisory panel: Cardiovascular
Date received: 2017-06-19
Decision date: 2018-01-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

Download summary PDF View on FDA.gov ↗

Adverse events under product code DQY

product code DQY

Death: 464
Injury: 4,489
Malfunction: 13,721
Other: 2
Total: 18,676

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.