FDA 510(k)

銀鷹周邊斑塊切除系統，超鷹周邊斑塊切除系統

K 號：K170191 · 2017-06-16

決定日期2017-06-16

產品代碼MCW

諮詢委員會履歷

決定相當於

器材摘要

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Vascular, Inc.. It received FDA 510(k) clearance on 2017-06-16 under 510(k) number K170191. The device is classified under product code MCW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is a medical device that received FDA 510(k) clearance on 2017-06-16. The listed applicant is Medtronic Vascular, Inc.. The 510(k) number is K170191.

When did SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System receive FDA 510(k) clearance?

SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System received FDA 510(k) clearance on 2017-06-16, under 510(k) number K170191.

Who is the listed applicant for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

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

What is the FDA product code for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System?

The FDA product code for SilverHawk Peripheral Plaque Excision System, TurboHawk Peripheral Plaque Excision System is MCW.

其他以 Medtronic Vascular, Inc. 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。

K182957Heli-FX內視鏡固定系統 K171866Sentrant 引導鞘，具有親水塗層 K171427Heli-FX 滴劑器，Heli-FX 引導器，輔助內科Anchor卡匣 K161361HawkOne 定向動脈內切除系統

相關器械（代碼：MCW）

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。

K260244Auryon 開心術系統Eximo Medical K250723FreedomFlow™ 軌道環形動脈內脫落術系統 (H6005/ 4Fr 3-球體配置)Cardio Flow Inc.,K250385超級精英雷射動脈內切除針Spectranetics K242757Rotarex 銳術系統Bard Peripheral Vascular, Inc.K242947FreedomFlow™ 軌道環形動脈內切除系統Cardio Flow Inc.,K241553Auryon 腺切除导管 1.7mm; Auryon 腺切除导管 1.7mm, 水性塗層Eximo Medical, Ltd.

官方來源

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