FDA 510(k)

X°Port Lung Preservation System; X°Port Lung Preservation Solution

K-번호: K243870 · 2025-05-01

결정일2025-05-01

제품 코드KDN

자문 위원회GU

결정Substantially Equivalent

기기 요약

X°Port Lung Preservation System; X°Port Lung Preservation Solution is the device name listed in this FDA 510(k) record. The listed applicant is Traferox Technologies, Inc.. It received FDA 510(k) clearance on 2025-05-01 under 510(k) number K243870. The device is classified under product code KDN. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the X°Port Lung Preservation System; X°Port Lung Preservation Solution?

X°Port Lung Preservation System; X°Port Lung Preservation Solution is a medical device that received FDA 510(k) clearance on 2025-05-01. The listed applicant is Traferox Technologies, Inc.. The 510(k) number is K243870.

When did X°Port Lung Preservation System; X°Port Lung Preservation Solution receive FDA 510(k) clearance?

X°Port Lung Preservation System; X°Port Lung Preservation Solution received FDA 510(k) clearance on 2025-05-01, under 510(k) number K243870.

Who is the listed applicant for X°Port Lung Preservation System; X°Port Lung Preservation Solution?

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

What is the FDA product code for X°Port Lung Preservation System; X°Port Lung Preservation Solution?

The FDA product code for X°Port Lung Preservation System; X°Port Lung Preservation Solution is KDN.

Traferox Technologies, Inc.를 신청인으로 등재한 기타 기록

K261913X°Port Heart Preservation System K260456VI°Port™ Liver Preservation System K240650LungProtect

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