FDA 510(k)

BD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）

K番号: K200266 · 2020-04-07

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

決定日2020-04-07

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 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.

よくある質問

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.

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

K190855BD アクートセンタルライン

公式ソース

FDAデータベースで見る →

データはFDA Open APIから取得しています。最新かつ権威ある情報については、常に公式レコードを参照してください。