FDA 510(k)

預設輕量型血栓切除裝置

K 號：K231539 · 2023-10-21

決定日期2023-10-21

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 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 2023-10-21 under 510(k) number K231539. 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 LITE Thrombectomy Device?

pRESET LITE Thrombectomy Device is a medical device that received FDA 510(k) clearance on 2023-10-21. The listed applicant is Phenox Limited. The 510(k) number is K231539.

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

pRESET LITE Thrombectomy Device received FDA 510(k) clearance on 2023-10-21, under 510(k) number K231539.

Who is the listed applicant for pRESET 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 LITE Thrombectomy Device?

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

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。

K242676預設Delta血栓切除裝置及預設Delta LITE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。

K242676預設Delta血栓切除裝置及預設Delta LITE血栓切除裝置Phenox Limited K223305Trevo NXT ProVue 抓取器Stryker Neurovascular K222848預設血栓切除裝置Phenox Limited K210502Trevo NXT ProVue 抓取器Stryker Neurovascular K203358單一花束 X 再血管化設備Micro Therapeutics, Inc. d/b/a ev3 Neurovascular K203219Trevo XP ProVue Retriever 及 Trevo NXT™ ProVue RetrieverStryker Neurovascular

官方來源

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