FDA 510(k)

FLASH Flex™ 大動脈-开口部血管内成形術システム

K番号: K254022 · 2026-04-02

決定日2026-04-02

製品コードLOX

諮問委員会以下は、提供された医療機器規制テキストの日本語訳です。 --- **政策：medical-regulatory-v1** --- [ここに原文が記載されています] --- **会社名/製品名**：[ここに会社名または製品名が記載されています] **FDA**：食品医薬品局 **510(k)**：510(k)届出 **PMA**：プレマーケティング評価届出 **NCT**：臨床試験登録番号 **PMID**：PubMed ID **識別子**：[ここに識別子が記載されています] **URL**：[ここにURLが記載されています]

決定Substantially Equivalent

医療機器の概要

FLASH Flex™ Aorto-Ostial Angioplasty System is the device name listed in this FDA 510(k) record. The listed applicant is Verge Medical, Inc.. It received FDA 510(k) clearance on 2026-04-02 under 510(k) number K254022. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the FLASH Flex™ Aorto-Ostial Angioplasty System?

FLASH Flex™ Aorto-Ostial Angioplasty System is a medical device that received FDA 510(k) clearance on 2026-04-02. The listed applicant is Verge Medical, Inc.. The 510(k) number is K254022.

When did FLASH Flex™ Aorto-Ostial Angioplasty System receive FDA 510(k) clearance?

FLASH Flex™ Aorto-Ostial Angioplasty System received FDA 510(k) clearance on 2026-04-02, under 510(k) number K254022.

Who is the listed applicant for FLASH Flex™ Aorto-Ostial Angioplasty System?

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

What is the FDA product code for FLASH Flex™ Aorto-Ostial Angioplasty System?

The FDA product code for FLASH Flex™ Aorto-Ostial Angioplasty System is LOX.

申請者としてVerge Medical, Inc.を記載するその他の記録

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