FDA 510(k)

克洛諾斯HP PTA 機械導管球囊

K 號：K190037 · 2019-10-24

決定日期2019-10-24

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Cronus HP PTA Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Nipro Medical Corporation. It received FDA 510(k) clearance on 2019-10-24 under 510(k) number K190037. The device is classified under product code LIT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Cronus HP PTA Balloon Catheter?

Cronus HP PTA Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-10-24. The listed applicant is Nipro Medical Corporation. The 510(k) number is K190037.

When did Cronus HP PTA Balloon Catheter receive FDA 510(k) clearance?

Cronus HP PTA Balloon Catheter received FDA 510(k) clearance on 2019-10-24, under 510(k) number K190037.

Who is the listed applicant for Cronus HP PTA Balloon Catheter?

FDA 510(k) 記錄中將 Nipro 医療公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Cronus HP PTA Balloon Catheter?

The FDA product code for Cronus HP PTA Balloon Catheter is LIT.

其他以 Nipro Medical Corporation 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：LIT）

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。

K260416ZYLOX Hippo PTA 擴張球囊心导管Zylox Medtech Co., Ltd.K254212NC PTA 機械擴張導管Kossel Medtech (Suzhou) Co., Ltd.K260304WAVE PTA 機器人球囊心导管WAVE Medical AG K252512Armada™ 14 NC PTA 穿刺導管ABBOTT MEDICAL K251915Amethyst HP PTA OTW 0.035 腔管Natec Medical , Ltd.K250706Passeo-35 Xeo 周邊擴張導管；Passeo-18 周邊擴張導管；Passeo-14 周邊擴張導管；Oscar 周邊多功能導管系統；Pantera Pro 射穿性經皮冠狀動脈成形術導管；Pantera LEO 射穿性經皮冠狀動脈成形術（PTCA）導管Biotronik, Inc.

官方來源

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