FDA 510(k)

디루멘 엔도루멘널 인터베뉴셔션 플랫폼

K-번호: K182540 · 2018-10-30

결정일2018-10-30

제품 코드FDF

자문 위원회규제 정책: medical-regulatory-v1 GU

결정대체적으로 동일

기기 요약

DiLumen Endolumenal Interventional Platform is the device name listed in this FDA 510(k) record. The listed applicant is Lumendi, LLC. It received FDA 510(k) clearance on 2018-10-30 under 510(k) number K182540. The device is classified under product code FDF. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the DiLumen Endolumenal Interventional Platform?

DiLumen Endolumenal Interventional Platform is a medical device that received FDA 510(k) clearance on 2018-10-30. The listed applicant is Lumendi, LLC. The 510(k) number is K182540.

When did DiLumen Endolumenal Interventional Platform receive FDA 510(k) clearance?

DiLumen Endolumenal Interventional Platform received FDA 510(k) clearance on 2018-10-30, under 510(k) number K182540.

Who is the listed applicant for DiLumen Endolumenal Interventional Platform?

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

What is the FDA product code for DiLumen Endolumenal Interventional Platform?

The FDA product code for DiLumen Endolumenal Interventional Platform is FDF.

Lumendi, LLC를 신청인으로 등재한 기타 기록

K221452디루멘 C1, EZ1, 도구 마운트 K211819디루멘 C2 및 도구 마운트 K210851디루멘 엔도루멘널 인터베뉴셔널 플랫폼 (디루멘)K183112디루멘 엔도루멘널 인터베뉴셔널 나이프 (“디루멘 IK™”）K173405디루멘 엔도루멘널 인터베뉴셔널 캔터(DiLumen Is)K173317디루멘 C2; 디루멘 도구 마운트

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