FDA 510(k)

메드소스 트루세이프 블러드 컨트롤 I.V. 세이프티 캐빗터, 그리고 메드소스 클리어세이프 블러드 컨트롤 I.V. 세이프티 캐빗터

K-번호: K223788 · 2023-09-15

결정일2023-09-15

제품 코드FOZ

자문 위원회의료장비 규제 텍스트 번역 HO [원문 텍스트가 제공되지 않았기 때문에 번역할 수 없습니다. 원문 텍스트를 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Medsource International, LLC. It received FDA 510(k) clearance on 2023-09-15 under 510(k) number K223788. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is a medical device that received FDA 510(k) clearance on 2023-09-15. The listed applicant is Medsource International, LLC. The 510(k) number is K223788.

When did The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter receive FDA 510(k) clearance?

The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter received FDA 510(k) clearance on 2023-09-15, under 510(k) number K223788.

Who is the listed applicant for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

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

What is the FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter?

The FDA product code for The MedSource TrueSafe Blood Control I.V. Safety Catheter, and the MedSource ClearSafe Blood Control I.V. Safety Catheter is FOZ.

Medsource International, LLC를 신청인으로 등재한 기타 기록

K161779메드소스 트루세이프 세이프티 IV 캐빈터, 메드소스 트루세이프 컴포트 세이프티 IV 캐빈터

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