FDA 510(k)

Protégé™ EverFlex™ Self-expanding Peripheral Stent System

K番号: K262913 · 2026-09-17

決定日2026-09-17

製品コードFGE

諮問委員会以下は、指定された医療機器規制テキストの日本語訳です。以下の医療機器規制テキストを日本語に翻訳してください。会社名、製品名、FDA、510(k)、PMA、NCT、PMID、識別子、およびURLを保護してください。ポリシー：medical-regulatory-v1 [原文] GU [翻訳] GU

決定Substantially Equivalent

医療機器の概要

Protégé™ EverFlex™ Self-expanding Peripheral Stent System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2026-09-17 under 510(k) number K262913. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Protégé™ EverFlex™ Self-expanding Peripheral Stent System?

Protégé™ EverFlex™ Self-expanding Peripheral Stent System is a medical device that received FDA 510(k) clearance on 2026-09-17. The listed applicant is Medtronic, Inc.. The 510(k) number is K262913.

When did Protégé™ EverFlex™ Self-expanding Peripheral Stent System receive FDA 510(k) clearance?

Protégé™ EverFlex™ Self-expanding Peripheral Stent System received FDA 510(k) clearance on 2026-09-17, under 510(k) number K262913.

Who is the listed applicant for Protégé™ EverFlex™ Self-expanding Peripheral Stent System?

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

What is the FDA product code for Protégé™ EverFlex™ Self-expanding Peripheral Stent System?

The FDA product code for Protégé™ EverFlex™ Self-expanding Peripheral Stent System is FGE.

申請者としてMedtronic, Inc.を記載するその他の記録

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公式ソース

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