FDA 510(k)

아리서 브로드 캡스드 시스템 드러그 트랜스퍼 디바이스 (CSTD)

K-번호: K201422 · 2021-03-02

결정일2021-03-02

제품 코드ONB

자문 위원회HO

결정Substantially Equivalent

기기 요약

Arisure Closed System Drug Transfer Device (CSTD) is the device name listed in this FDA 510(k) record. The listed applicant is Yukon Medical, LLC. It received FDA 510(k) clearance on 2021-03-02 under 510(k) number K201422. The device is classified under product code ONB. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the Arisure Closed System Drug Transfer Device (CSTD)?

Arisure Closed System Drug Transfer Device (CSTD) is a medical device that received FDA 510(k) clearance on 2021-03-02. The listed applicant is Yukon Medical, LLC. The 510(k) number is K201422.

When did Arisure Closed System Drug Transfer Device (CSTD) receive FDA 510(k) clearance?

Arisure Closed System Drug Transfer Device (CSTD) received FDA 510(k) clearance on 2021-03-02, under 510(k) number K201422.

Who is the listed applicant for Arisure Closed System Drug Transfer Device (CSTD)?

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

What is the FDA product code for Arisure Closed System Drug Transfer Device (CSTD)?

The FDA product code for Arisure Closed System Drug Transfer Device (CSTD) is ONB.

Yukon Medical, LLC를 신청인으로 등재한 기타 기록

K240761Arisure® Closed Male Luer with Spike Adapter (YM060)K243486SmartSiteTM Vented Vial Access Device

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