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FDA 510(k)

Solitaire Platinum Revascularization Device

K 號：K161879 · 2016-09-21

申請人Micro Therapeutics, Inc. d/b/a ev3 Neurovascular
決定日期2016-09-21
產品代碼NRY
諮詢委員會CV
決定Substantially Equivalent

器材摘要

Solitaire Platinum Revascularization Device is the device name listed in this FDA 510(k) record. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. It received FDA 510(k) clearance on 2016-09-21 under 510(k) number K161879. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Solitaire Platinum Revascularization Device?

Solitaire Platinum Revascularization Device is a medical device that received FDA 510(k) clearance on 2016-09-21. The listed applicant is Micro Therapeutics, Inc. d/b/a ev3 Neurovascular. The 510(k) number is K161879.

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

Solitaire Platinum Revascularization Device received FDA 510(k) clearance on 2016-09-21, under 510(k) number K161879.

Who is the listed applicant for Solitaire Platinum Revascularization Device?

The FDA 510(k) record lists Micro Therapeutics, Inc. d/b/a ev3 Neurovascular as the applicant. This does not by itself establish the device manufacturer.

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

The FDA product code for Solitaire Platinum Revascularization Device is NRY.

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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其他以 Micro Therapeutics, Inc. d/b/a ev3 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。

K241388Rist 079 Radial Access Guide Catheter; Rist 071 Radial Access Guide Catheter; Rist Radial Access Selective CatheterK243418Riptide™ Aspiration Pump; Riptide™ Collection Canister with Intermediate TubingK243080Riptide Aspiration SystemK211990Rist 071 Radial Access Guide CatheterK203432Axium Detachable Coil; Axium Prime Detachable CoilK203358Solitaire X Revascularization Device

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相關器械（代碼：NRY）

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。

K261089Radical 064 Reperfusion Catheter; Radical 076 Reperfusion Catheter; Radical Aspiration Tubing KitMaduro Medical, Inc.K260617Tigertriever 13 Ultra Revascularization DeviceRapid Medical Ltd.K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK262399Millipede SystemPerfuze, Ltd.K260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.

官方來源

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