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FDA 510(k)

EsoCool 體溫調節針管

K 號：K233357 · 2024-06-27

申請人Nuvaira, Inc.
決定日期2024-06-27
產品代碼PLA
諮詢委員會履歷
決定相當於

器材摘要

EsoCool Thermal Regulation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nuvaira, Inc.. It received FDA 510(k) clearance on 2024-06-27 under 510(k) number K233357. 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 EsoCool Thermal Regulation Catheter?

EsoCool Thermal Regulation Catheter is a medical device that received FDA 510(k) clearance on 2024-06-27. The listed applicant is Nuvaira, Inc.. The 510(k) number is K233357.

When did EsoCool Thermal Regulation Catheter receive FDA 510(k) clearance?

EsoCool Thermal Regulation Catheter received FDA 510(k) clearance on 2024-06-27, under 510(k) number K233357.

Who is the listed applicant for EsoCool Thermal Regulation Catheter?

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

What is the FDA product code for EsoCool Thermal Regulation Catheter?

The FDA product code for EsoCool Thermal Regulation Catheter 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。

K250632Arctx 冷觸發導管組Arctx MedicalK180742EnsoETMAdvanced 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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