FDA 510(k)

BD Prevue II 주위혈관 주사 접근 시스템

K-번호: K211193 · 2021-06-25

신청자Bard Access Systems, Inc. (C.R. Bard, Inc.)

결정일2021-06-25

제품 코드IYO

자문 위원회[원문이 제공되지 않았기 때문에 번역할 수 없습니다. 원문을 제공해 주시면 번역을 도와드리겠습니다.]

결정대체적으로 동일

기기 요약

BD Prevue II Peripheral Vascular Vascular Access System is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). It received FDA 510(k) clearance on 2021-06-25 under 510(k) number K211193. The device is classified under product code IYO. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the BD Prevue II Peripheral Vascular Vascular Access System?

BD Prevue II Peripheral Vascular Vascular Access System is a medical device that received FDA 510(k) clearance on 2021-06-25. The listed applicant is Bard Access Systems, Inc. (C.R. Bard, Inc.). The 510(k) number is K211193.

When did BD Prevue II Peripheral Vascular Vascular Access System receive FDA 510(k) clearance?

BD Prevue II Peripheral Vascular Vascular Access System received FDA 510(k) clearance on 2021-06-25, under 510(k) number K211193.

Who is the listed applicant for BD Prevue II Peripheral Vascular Vascular Access System?

The FDA 510(k) record lists Bard Access Systems, Inc. (C.R. Bard, Inc.) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BD Prevue II Peripheral Vascular Vascular Access System?

The FDA product code for BD Prevue II Peripheral Vascular Vascular Access System is IYO.

Bard Access Systems, Inc. (C.R. Bard, Inc.)를 신청인으로 등재한 기타 기록

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