FDA 510(k)

埃博尼HP PTA OTW 0.035 腹腔鏈管

K 號：K220410 · 2022-06-29

決定日期2022-06-29

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

Ebony HP PTA OTW 0.035 Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Natec Medical , Ltd.. It received FDA 510(k) clearance on 2022-06-29 under 510(k) number K220410. 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 Ebony HP PTA OTW 0.035 Catheter?

Ebony HP PTA OTW 0.035 Catheter is a medical device that received FDA 510(k) clearance on 2022-06-29. The listed applicant is Natec Medical , Ltd.. The 510(k) number is K220410.

When did Ebony HP PTA OTW 0.035 Catheter receive FDA 510(k) clearance?

Ebony HP PTA OTW 0.035 Catheter received FDA 510(k) clearance on 2022-06-29, under 510(k) number K220410.

Who is the listed applicant for Ebony HP PTA OTW 0.035 Catheter?

The FDA 510(k) record lists Natec Medical , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ebony HP PTA OTW 0.035 Catheter?

The FDA product code for Ebony HP PTA OTW 0.035 Catheter is LIT.

其他以 Natec Medical , Ltd. 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。

K251915Amethyst HP PTA OTW 0.035 腔管 K241040Amethyst HP PTA OTW 0.035 腔管 K210012Tamarin藍PTCA RX 膨脹導管

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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