CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE)— 510(k) K140338

Substantially Equivalent

Creganna-Tactx Medical

FDA 510(k) clearance K140338 for CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX LOTUS INTRODUCER SET (LARGE), Substantially Equivalent on 2014-08-27. Applicant: Creganna-Tactx Medical.

Clearance details

Applicant: Creganna-Tactx Medical
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 2014-02-10
Decision date: 2014-08-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Galway, IE

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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.