FDA 510(k)

Trevo NXT ProVue 抓取器

K 號：K210502 · 2021-08-27

決定日期2021-08-27

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

Trevo NXT ProVue Retriever is the device name listed in this FDA 510(k) record. The listed applicant is Stryker Neurovascular. It received FDA 510(k) clearance on 2021-08-27 under 510(k) number K210502. 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 Trevo NXT ProVue Retriever?

Trevo NXT ProVue Retriever is a medical device that received FDA 510(k) clearance on 2021-08-27. The listed applicant is Stryker Neurovascular. The 510(k) number is K210502.

When did Trevo NXT ProVue Retriever receive FDA 510(k) clearance?

Trevo NXT ProVue Retriever received FDA 510(k) clearance on 2021-08-27, under 510(k) number K210502.

Who is the listed applicant for Trevo NXT ProVue Retriever?

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

What is the FDA product code for Trevo NXT ProVue Retriever?

The FDA product code for Trevo NXT ProVue Retriever is POL.

其他以 Stryker Neurovascular 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。

K261889Trevo Trak 21 微导管 K253032AXS Lift 颅内基底導管 K252694目標可拆式線圈 K251832InZone IST 分離系統；IZDS 連接線 K242289Excelsior XT-27 微导管，Excelsior XT-27 強化微导管，Excelsior XT-27 預成型微导管，Excelsior XT-27 強化預成型微导管 K243593AXS Lift 颅内基底導管

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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 K231539預設輕量型血栓切除裝置Phenox Limited K223305Trevo NXT ProVue 抓取器Stryker Neurovascular K222848預設血栓切除裝置Phenox Limited 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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