FDA 510(k)

HOTWIRE RF GUIDEWIRE（901XXX）；HOTWIRE RF GUIDEWIRE（902XXX）

K番号: K260292 · 2026-02-27

決定日2026-02-27

製品コードDXF

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

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is the device name listed in this FDA 510(k) record. The listed applicant is Atraverse Medical. It received FDA 510(k) clearance on 2026-02-27 under 510(k) number K260292. The device is classified under product code DXF. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

よくある質問

What is the HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is a medical device that received FDA 510(k) clearance on 2026-02-27. The listed applicant is Atraverse Medical. The 510(k) number is K260292.

When did HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) receive FDA 510(k) clearance?

HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) received FDA 510(k) clearance on 2026-02-27, under 510(k) number K260292.

Who is the listed applicant for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

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

What is the FDA product code for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX)?

The FDA product code for HOTWIRE RF GUIDEWIRE (901XXX); HOTWIRE RF GUIDEWIRE (902XXX) is DXF.

申請者としてAtraverse Medicalを記載するその他の記録

K240900HOTWIRE™ RFガイドワイヤー

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