FDA 510(k)

Merit MAK Nitinol/Gold-Tungsten Guide Wire

K番号: K261640 · 2026-07-13

決定日2026-07-13

製品コードDQX

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

Merit MAK Nitinol/Gold-Tungsten Guide Wire is the device name listed in this FDA 510(k) record. The listed applicant is Merit Medical Ireland , Ltd.. It received FDA 510(k) clearance on 2026-07-13 under 510(k) number K261640. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the Merit MAK Nitinol/Gold-Tungsten Guide Wire?

Merit MAK Nitinol/Gold-Tungsten Guide Wire is a medical device that received FDA 510(k) clearance on 2026-07-13. The listed applicant is Merit Medical Ireland , Ltd.. The 510(k) number is K261640.

When did Merit MAK Nitinol/Gold-Tungsten Guide Wire receive FDA 510(k) clearance?

Merit MAK Nitinol/Gold-Tungsten Guide Wire received FDA 510(k) clearance on 2026-07-13, under 510(k) number K261640.

Who is the listed applicant for Merit MAK Nitinol/Gold-Tungsten Guide Wire?

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

What is the FDA product code for Merit MAK Nitinol/Gold-Tungsten Guide Wire?

The FDA product code for Merit MAK Nitinol/Gold-Tungsten Guide Wire is DQX.

申請者としてMerit Medical Ireland , Ltd.を記載するその他の記録

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