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FDA 510(k)

Arctx 冷觸發導管組

K 號：K250632 · 2025-10-30

申請人Arctx Medical
決定日期2025-10-30
產品代碼PLA
諮詢委員會履歷
決定相當於

器材摘要

Arctx Cool Catheter Set is the device name listed in this FDA 510(k) record. The listed applicant is Arctx Medical. It received FDA 510(k) clearance on 2025-10-30 under 510(k) number K250632. The device is classified under product code PLA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Arctx Cool Catheter Set?

Arctx Cool Catheter Set is a medical device that received FDA 510(k) clearance on 2025-10-30. The listed applicant is Arctx Medical. The 510(k) number is K250632.

When did Arctx Cool Catheter Set receive FDA 510(k) clearance?

Arctx Cool Catheter Set received FDA 510(k) clearance on 2025-10-30, under 510(k) number K250632.

Who is the listed applicant for Arctx Cool Catheter Set?

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

What is the FDA product code for Arctx Cool Catheter Set?

The FDA product code for Arctx Cool Catheter Set is PLA.

相關臨床試驗

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

相關器械（代碼：PLA）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

K233357EsoCool 體溫調節針管Nuvaira, Inc.K180742EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune MedicalK180244EnsoETMAdvanced Cooling Therapy, Inc. D/B/A Attune MedicalK172029EnsoETMAttune MedicalK172493EnsoETMAttune MedicalK170009食道冷卻裝置Advanced Cooling Therapy, LLC

官方來源

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