FDA 510(k)

BD アクートセンタルライン

K番号: K190855 · 2019-11-01

申請者Bard Access Systems, Inc. (Bard Has Joined Bd)

決定日2019-11-01

製品コードFOZ

諮問委員会医療機器規制テキストの翻訳は以下の通りです。 HO [翻訳が提供されなかったため、原文の「HO」がそのまま使用されます]

決定大幅同等

医療機器の概要

BD Acute Central Line 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 2019-11-01 under 510(k) number K190855. The device is classified under product code FOZ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the BD Acute Central Line?

BD Acute Central Line is a medical device that received FDA 510(k) clearance on 2019-11-01. The listed applicant is Bard Access Systems, Inc. (Bard Has Joined Bd). The 510(k) number is K190855.

When did BD Acute Central Line receive FDA 510(k) clearance?

BD Acute Central Line received FDA 510(k) clearance on 2019-11-01, under 510(k) number K190855.

Who is the listed applicant for BD Acute Central Line?

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 Acute Central Line?

The FDA product code for BD Acute Central Line is FOZ.

申請者としてBard Access Systems, Inc. (Bard Has Joined Bd)を記載するその他の記録

K200266BDセントロベナアキュート中央静脈ライン（7フランスダブルルーメン）

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