FDA 510(k)

BD 센트로 베나 급성 중추선(7 프랑스 더블 루멘)

K-번호: K200266 · 2020-04-07

신청자Bard Access Systems, Inc. (Bard Has Joined Bd)

결정일2020-04-07

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

BD Centro Vena Acute Central Line (7 French Dual Lumen) is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). It received FDA 510(k) clearance on 2020-04-07 under 510(k) number K200266. 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 BD Centro Vena Acute Central Line (7 French Dual Lumen)?

BD Centro Vena Acute Central Line (7 French Dual Lumen) is a medical device that received FDA 510(k) clearance on 2020-04-07. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). The 510(k) number is K200266.

When did BD Centro Vena Acute Central Line (7 French Dual Lumen) receive FDA 510(k) clearance?

BD Centro Vena Acute Central Line (7 French Dual Lumen) received FDA 510(k) clearance on 2020-04-07, under 510(k) number K200266.

Who is the listed applicant for BD Centro Vena Acute Central Line (7 French Dual Lumen)?

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

What is the FDA product code for BD Centro Vena Acute Central Line (7 French Dual Lumen)?

The FDA product code for BD Centro Vena Acute Central Line (7 French Dual Lumen) is FOZ.

Bard Access Systems, Inc. (Bard Has Joined Bd)를 신청인으로 등재한 기타 기록

K190855BD 급성 중추선

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