FDA 510(k)

鑽石背360周邊循環動脈切除系統，Stealth 360周邊循環動脈切除系統

K 號：K190634 · 2019-07-02

決定日期2019-07-02

產品代碼MCW

諮詢委員會履歷

決定相當於

器材摘要

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascular Systems, Inc.. It received FDA 510(k) clearance on 2019-07-02 under 510(k) number K190634. 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 Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System?

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System is a medical device that received FDA 510(k) clearance on 2019-07-02. The listed applicant is Cardiovascular Systems, Inc.. The 510(k) number is K190634.

When did Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System receive FDA 510(k) clearance?

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System received FDA 510(k) clearance on 2019-07-02, under 510(k) number K190634.

Who is the listed applicant for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System?

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

What is the FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System?

The FDA product code for Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System is MCW.

其他以 Cardiovascular Systems, 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。

K220109DIAMONDBACK 360周邊 orbital動脈粥樣硬化切除系統，DIAMONDBACK 360周邊 orbital動脈粥樣硬化切除系統，可交換系列，Stealth 360周邊 orbital動脈粥樣硬化切除系統 K212725ViperCross 支援導管 K210586Diamonback 360 周邊 orbital 腦中風切除系統，Diamondback 360 Stealth orbital 腦中風切除系統 K211240ViperCross 支援導管 K211251ViperCath XC 頸外周交換導管 K210282WIRION 體內栓塊防護系統

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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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