FDA PMA

내부혈관 시스템, 토라코아브도마일 및 파라렌알主动脉 병변 치료용

PMA 번호: P230023 · 2026-07-01

결정일2026-07-01

PMA 번호P230023

제품 코드QZK

의료기기 등급등급 3

의학적 전문분야U

자문 위원회의료장비 규제 텍스트 번역 [회사명]의 [제품명]은 미국 식약국(FDA)에 등록된 의료장비로, 510(k) 신청을 통해 승인받았습니다. PMA(Premarket Approval) 신청이 진행 중이며, 연구 등록 번호(NCT)는 [NCT 번호]입니다. 논문 등록 번호(PMID)는 [PMID 번호]입니다. 더 자세한 정보는 다음 URL을 참조하세요: [URL] 정책: medical-regulatory-v1

기기 요약

Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions is the device name listed in this FDA 510(k) record. The listed applicant is W. L. Gore & Associates, Inc.. It received FDA 510(k) clearance on 2026-07-01. The device is classified under product code QZK. It was reviewed by the CV advisory panel.

자주 묻는 질문

What is the Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions?

Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions is a medical device that received FDA 510(k) clearance on 2026-07-01. The listed applicant is W. L. Gore & Associates, Inc..

When did Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions receive FDA 510(k) clearance?

The clearance date for Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions can be found in the official FDA records.

Who is the listed applicant for Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions?

The FDA 510(k) record lists W. L. Gore & Associates, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions?

The FDA product code for Endovascular system for treatment of thoracoabdominal and pararenal aortic lesions is QZK.

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