FDA 510(k)

Viatrac 14 Plus 頸動脈擴張針管

K 號：K221057 · 2022-05-05

決定日期2022-05-05

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Viatrac 14 Plus Peripheral Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Vascular. It received FDA 510(k) clearance on 2022-05-05 under 510(k) number K221057. 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 Viatrac 14 Plus Peripheral Dilatation Catheter?

Viatrac 14 Plus Peripheral Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-05-05. The listed applicant is Abbott Vascular. The 510(k) number is K221057.

When did Viatrac 14 Plus Peripheral Dilatation Catheter receive FDA 510(k) clearance?

Viatrac 14 Plus Peripheral Dilatation Catheter received FDA 510(k) clearance on 2022-05-05, under 510(k) number K221057.

Who is the listed applicant for Viatrac 14 Plus Peripheral Dilatation Catheter?

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

What is the FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter?

The FDA product code for Viatrac 14 Plus Peripheral Dilatation Catheter is LIT.

其他以 Abbott Vascular 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。

K220634NC TREK NEO 冠狀擴張導管 K201834HI-TORQUE PROCEED 線導管系列 K200144高扭矩鋼芯裸導引絲 K193126HI-TORQUE InfilTrac 導引絲系列 K191173Emboshield NAV6 體內栓子防護系統，裸線過濾導線 K180040NC TREK™ RX 冠狀動脈擴張導管；NC TREK™ OTW 冠狀動脈擴張導管；TREK™ RX 冠狀動脈擴張導管；TREK™ OTW 冠狀動脈擴張導管；MINI TREK™ RX 冠狀動脈擴張導管；MINI TREK™ OTW 冠狀動脈擴張導管；MINI TREK™ II OTW 冠狀動脈擴張導管

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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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