FDA 510(k)

Introcan Safety 3 閉じ込め型静脈カテーテル

K番号: K163358 · 2017-04-28

決定日2017-04-28

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

Introcan Safety 3 Closed IV Catheter is the device name listed in this FDA 510(k) record. The listed applicant is B.Braun Melsungen AG. It received FDA 510(k) clearance on 2017-04-28 under 510(k) number K163358. 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 Introcan Safety 3 Closed IV Catheter?

Introcan Safety 3 Closed IV Catheter is a medical device that received FDA 510(k) clearance on 2017-04-28. The listed applicant is B.Braun Melsungen AG. The 510(k) number is K163358.

When did Introcan Safety 3 Closed IV Catheter receive FDA 510(k) clearance?

Introcan Safety 3 Closed IV Catheter received FDA 510(k) clearance on 2017-04-28, under 510(k) number K163358.

Who is the listed applicant for Introcan Safety 3 Closed IV Catheter?

The FDA 510(k) record lists B.Braun Melsungen AG as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Introcan Safety 3 Closed IV Catheter?

The FDA product code for Introcan Safety 3 Closed IV Catheter is FOZ.

申請者としてB.Braun Melsungen AGを記載するその他の記録

K152050ペンシルキャップ

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