FDA 510(k)

Splashwire 水親和性ガイドワイヤー（MSWSTD35150J3）

K番号: K253847 · 2026-01-31

決定日2026-01-31

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]

決定大幅同等

医療機器の概要

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) 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 2026-01-31 under 510(k) number K253847. 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 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) is a medical device that received FDA 510(k) clearance on 2026-01-31. The listed applicant is Merit Medical Ireland, Ltd.. The 510(k) number is K253847.

When did Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) receive FDA 510(k) clearance?

Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) received FDA 510(k) clearance on 2026-01-31, under 510(k) number K253847.

Who is the listed applicant for Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

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 Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)?

The FDA product code for Splashwire Hydrophilic Guide Wire (MSWSTD35150J3) 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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