FDA 510(k)

ハイドロピック 5F ドゥアルルーメンカテーテル

K番号: K213550 · 2022-05-04

決定日2022-05-04

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

HydroPICC 5F Dual Lumen Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Access Vascular, Inc.. It received FDA 510(k) clearance on 2022-05-04 under 510(k) number K213550. 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 HydroPICC 5F Dual Lumen Catheter?

HydroPICC 5F Dual Lumen Catheter is a medical device that received FDA 510(k) clearance on 2022-05-04. The listed applicant is Access Vascular, Inc.. The 510(k) number is K213550.

When did HydroPICC 5F Dual Lumen Catheter receive FDA 510(k) clearance?

HydroPICC 5F Dual Lumen Catheter received FDA 510(k) clearance on 2022-05-04, under 510(k) number K213550.

Who is the listed applicant for HydroPICC 5F Dual Lumen Catheter?

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

What is the FDA product code for HydroPICC 5F Dual Lumen Catheter?

The FDA product code for HydroPICC 5F Dual Lumen Catheter is LJS.

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

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