FDA 510(k)

デルタベンファストフラッシュクローズドイブカテターシステム

K番号: K200373 · 2020-08-26

決定日2020-08-26

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

Deltaven Fast Flash Closed I.V. Catheter Systems is the device name listed in this FDA 510(k) record. The listed applicant is Delta Med Spa. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K200373. 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 Deltaven Fast Flash Closed I.V. Catheter Systems?

Deltaven Fast Flash Closed I.V. Catheter Systems is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Delta Med Spa. The 510(k) number is K200373.

When did Deltaven Fast Flash Closed I.V. Catheter Systems receive FDA 510(k) clearance?

Deltaven Fast Flash Closed I.V. Catheter Systems received FDA 510(k) clearance on 2020-08-26, under 510(k) number K200373.

Who is the listed applicant for Deltaven Fast Flash Closed I.V. Catheter Systems?

The FDA 510(k) record lists Delta Med Spa as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems?

The FDA product code for Deltaven Fast Flash Closed I.V. Catheter Systems is FOZ.

申請者としてDelta Med Spaを記載するその他の記録

K171530デルタベン XiV Max、デルタベン XiV Max FF

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