PRAEVAorta®2— 510(k) K243859

Substantially Equivalent

Nurea

FDA 510(k) clearance K243859 for PRAEVAorta®2, Substantially Equivalent on 2025-08-29. Applicant: Nurea.

Clearance details

Applicant: Nurea
Product code: Code QIH
Advisory panel: Radiology
Date received: 2024-12-16
Decision date: 2025-08-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bègles, FR

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.