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FDA 510(k)

AeroJet 通氣導尿管

K 號：K243579 · 2025-08-13

申請人Pipeline Medical Products, LLC
決定日期2025-08-13
產品代碼BTR
諮詢委員會AN
決定相當於

器材摘要

AeroJet Ventilation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Pipeline Medical Products, LLC. It received FDA 510(k) clearance on 2025-08-13 under 510(k) number K243579. The device is classified under product code BTR. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the AeroJet Ventilation Catheter?

AeroJet Ventilation Catheter is a medical device that received FDA 510(k) clearance on 2025-08-13. The listed applicant is Pipeline Medical Products, LLC. The 510(k) number is K243579.

When did AeroJet Ventilation Catheter receive FDA 510(k) clearance?

AeroJet Ventilation Catheter received FDA 510(k) clearance on 2025-08-13, under 510(k) number K243579.

Who is the listed applicant for AeroJet Ventilation Catheter?

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

What is the FDA product code for AeroJet Ventilation Catheter?

The FDA product code for AeroJet Ventilation Catheter is BTR.

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：BTR）

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。

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官方來源

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