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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，鑽石背360周邊循環動脈切除系統可交換系列

K 號：K220568 · 2022-04-27

申請人Cardiovascualr Systems, Inc.
決定日期2022-04-27
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, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is the device name listed in this FDA 510(k) record. The listed applicant is Cardiovascualr Systems, Inc.. It received FDA 510(k) clearance on 2022-04-27 under 510(k) number K220568. 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 Exchangeable Series?

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series is a medical device that received FDA 510(k) clearance on 2022-04-27. The listed applicant is Cardiovascualr Systems, Inc.. The 510(k) number is K220568.

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

Diamondback 360 Peripheral Orbital Atherectomy System, Stealth 360 Peripheral Orbital Atherectomy System, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series received FDA 510(k) clearance on 2022-04-27, under 510(k) number K220568.

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

The FDA 510(k) record lists Cardiovascualr 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, Diamondback 360 Peripheral Orbital Atherectomy System Exchangeable Series?

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

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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 MedicalK250723FreedomFlow™ 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SpectraneticsK242757Rotarex 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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