FDA 510(k)

BD パワーピックカテーテル

K番号: K210264 · 2021-07-30

決定日2021-07-30

製品コードLJS

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 PowerPiCC Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Bard Access Systems, Inc.. It received FDA 510(k) clearance on 2021-07-30 under 510(k) number K210264. The device is classified under product code LJS. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the BD PowerPiCC Catheter?

BD PowerPiCC Catheter is a medical device that received FDA 510(k) clearance on 2021-07-30. The listed applicant is Bard Access Systems, Inc.. The 510(k) number is K210264.

When did BD PowerPiCC Catheter receive FDA 510(k) clearance?

BD PowerPiCC Catheter received FDA 510(k) clearance on 2021-07-30, under 510(k) number K210264.

Who is the listed applicant for BD PowerPiCC Catheter?

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

What is the FDA product code for BD PowerPiCC Catheter?

The FDA product code for BD PowerPiCC Catheter is LJS.

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

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