FDA 510(k)

オスプレイ・ミッドライン・クローズド・IV・キャスター・システム（OspreyEDC-F20）

K番号: K250292 · 2025-05-02

決定日2025-05-02

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

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is the device name listed in this FDA 510(k) record. The listed applicant is Skydance Vascular, Inc.. It received FDA 510(k) clearance on 2025-05-02 under 510(k) number K250292. 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 OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)?

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is a medical device that received FDA 510(k) clearance on 2025-05-02. The listed applicant is Skydance Vascular, Inc.. The 510(k) number is K250292.

When did OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) receive FDA 510(k) clearance?

OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) received FDA 510(k) clearance on 2025-05-02, under 510(k) number K250292.

Who is the listed applicant for OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)?

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

What is the FDA product code for OSPREY Midline Closed IV Catheter System (OspreyEDC-F20)?

The FDA product code for OSPREY Midline Closed IV Catheter System (OspreyEDC-F20) is FOZ.

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

K231626オスプレイ閉じ込め静脈カテーテルシステム（オスプレイV2）K223018オスプレイ周囲静脈カテーテルシステム

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