FDA 510(k)

Rotarex 銳術系統

K 號：K211738 · 2021-09-14

決定日期2021-09-14

產品代碼MCW

諮詢委員會履歷

決定相當於

器材摘要

Rotarex Atherectomy System is the device name listed in this FDA 510(k) record. The listed applicant is C.R. Bard, Inc.. It received FDA 510(k) clearance on 2021-09-14 under 510(k) number K211738. 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 Rotarex Atherectomy System?

Rotarex Atherectomy System is a medical device that received FDA 510(k) clearance on 2021-09-14. The listed applicant is C.R. Bard, Inc.. The 510(k) number is K211738.

When did Rotarex Atherectomy System receive FDA 510(k) clearance?

Rotarex Atherectomy System received FDA 510(k) clearance on 2021-09-14, under 510(k) number K211738.

Who is the listed applicant for Rotarex Atherectomy System?

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

What is the FDA product code for Rotarex Atherectomy System?

The FDA product code for Rotarex Atherectomy System is MCW.

其他以 C.R. Bard, 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。

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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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