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FDA 510(k)

預設Delta血栓切除裝置及預設Delta LITE血栓切除裝置

K 號：K242676 · 2025-02-28

申請人Phenox Limited
決定日期2025-02-28
產品代碼POL
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device is the device name listed in this FDA 510(k) record. The listed applicant is Phenox Limited. It received FDA 510(k) clearance on 2025-02-28 under 510(k) number K242676. The device is classified under product code POL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device?

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2025-02-28. The listed applicant is Phenox Limited. The 510(k) number is K242676.

When did pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device receive FDA 510(k) clearance?

pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device received FDA 510(k) clearance on 2025-02-28, under 510(k) number K242676.

Who is the listed applicant for pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device?

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

What is the FDA product code for pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device?

The FDA product code for pRESET Delta Thrombectomy Device and pRESET Delta LITE Thrombectomy Device is POL.

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

其他以 Phenox Limited 為申請人之記錄

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。

K231539預設輕量型血栓切除裝置K222848預設血栓切除裝置K191687pORTAL 可調向親水性導絲及 pORTAL EXT 延長導絲

相關器械（代碼：POL）

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。

K231539預設輕量型血栓切除裝置Phenox LimitedK223305Trevo NXT ProVue 抓取器Stryker NeurovascularK222848預設血栓切除裝置Phenox LimitedK210502Trevo NXT ProVue 抓取器Stryker NeurovascularK203358單一花束 X 再血管化設備Micro Therapeutics, Inc. d/b/a ev3 NeurovascularK203219Trevo XP ProVue Retriever 及 Trevo NXT™ ProVue RetrieverStryker Neurovascular

官方來源

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