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FDA 510(k)

PRAEVAorta®2

K-Number: K243859 · 2025-08-29

ApplicantNurea
Decision Date2025-08-29
Product CodeQIH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PRAEVAorta®2 is the device name listed in this FDA 510(k) record. The listed applicant is Nurea. It received FDA 510(k) clearance on 2025-08-29 under 510(k) number K243859. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PRAEVAorta®2?

PRAEVAorta®2 is a medical device that received FDA 510(k) clearance on 2025-08-29. The listed applicant is Nurea. The 510(k) number is K243859.

When did PRAEVAorta®2 receive FDA 510(k) clearance?

PRAEVAorta®2 received FDA 510(k) clearance on 2025-08-29, under 510(k) number K243859.

Who is the listed applicant for PRAEVAorta®2?

The FDA 510(k) record lists Nurea as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PRAEVAorta®2?

The FDA product code for PRAEVAorta®2 is QIH.

Related Devices (Code: QIH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253794Prostate CoreLucida Medical, Ltd.K252571mdprostateMediaire GmbHK253902RealGUIDE3DIEMME SRLK253835AffinityHermes Medical Solutions ABK260980cmAngio® V2.0Curemetrix, Inc.K261210Cleerly PlaqueCleerly, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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