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FDA 510(k)

單一2及單一白金再血管化設備

K 號：K181060 · 2018-08-24

申請人Medtronic Neurovascular
決定日期2018-08-24
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

Solitaire 2 and Solitaire Platinum Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Neurovascular. It received FDA 510(k) clearance on 2018-08-24 under 510(k) number K181060. 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 Solitaire 2 and Solitaire Platinum Revascularization Device?

Solitaire 2 and Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2018-08-24. The listed applicant is Medtronic Neurovascular. The 510(k) number is K181060.

When did Solitaire 2 and Solitaire Platinum Revascularization Device receive FDA 510(k) clearance?

Solitaire 2 and Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2018-08-24, under 510(k) number K181060.

Who is the listed applicant for Solitaire 2 and Solitaire Platinum Revascularization Device?

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

What is the FDA product code for Solitaire 2 and Solitaire Platinum Revascularization Device?

The FDA product code for Solitaire 2 and Solitaire Platinum Revascularization 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。

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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 LimitedK231539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 Neurovascular

官方來源

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