免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

巧克力 XD PTCA 機器人球囊导管

K 號：K153682 · 2016-06-23

申請人Trireme Medical, LLC
決定日期2016-06-23
產品代碼LOX
諮詢委員會履歷
決定相當於

器材摘要

Chocolate XD PTCA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Trireme Medical, LLC. It received FDA 510(k) clearance on 2016-06-23 under 510(k) number K153682. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Chocolate XD PTCA Balloon Catheter?

Chocolate XD PTCA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2016-06-23. The listed applicant is Trireme Medical, LLC. The 510(k) number is K153682.

When did Chocolate XD PTCA Balloon Catheter receive FDA 510(k) clearance?

Chocolate XD PTCA Balloon Catheter received FDA 510(k) clearance on 2016-06-23, under 510(k) number K153682.

Who is the listed applicant for Chocolate XD PTCA Balloon Catheter?

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

What is the FDA product code for Chocolate XD PTCA Balloon Catheter?

The FDA product code for Chocolate XD PTCA Balloon Catheter is LOX.

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：LOX）

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。

K261428NC Euphora 快速交換氣球擴張導管Medtronic IrelandK261759Euphora Rapid Exchange (RX) 機械擴張導管Medtronic IrelandK252116消防員™ Pro PTCA 機械導管Shanghai MicroPort Medical (Group) Co., Ltd.K254022FLASH Flex™ 頸動脈-近端動脈成形術系統Verge Medical, Inc.K252295龍煉Terumo CorporationK251970Sprinter Legend 快速交換氣球擴張導管Medtronic, Ireland

官方來源

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。

↑