Armada™ 14 NC PTA 穿刺導管
K 號：K252512 · 2026-02-13
廣告
器材摘要
Armada™ 14 NC PTA Catheter is the device name listed in this FDA 510(k) record. The listed applicant is ABBOTT MEDICAL. It received FDA 510(k) clearance on 2026-02-13 under 510(k) number K252512. 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 Armada™ 14 NC PTA Catheter?
Armada™ 14 NC PTA Catheter is a medical device that received FDA 510(k) clearance on 2026-02-13. The listed applicant is ABBOTT MEDICAL. The 510(k) number is K252512.
When did Armada™ 14 NC PTA Catheter receive FDA 510(k) clearance?
Armada™ 14 NC PTA Catheter received FDA 510(k) clearance on 2026-02-13, under 510(k) number K252512.
Who is the listed applicant for Armada™ 14 NC PTA Catheter?
The FDA 510(k) record lists ABBOTT MEDICAL as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Armada™ 14 NC PTA Catheter?
The FDA product code for Armada™ 14 NC PTA Catheter is LIT.
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。
其他以 ABBOTT MEDICAL 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。
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 AGK251915Amethyst 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.K243704Parafleet SC 014 PTA 擴張氣球導管；Parafleet SC 018 PTA 擴張氣球導管；Parafleet SC 035 PTA 擴張氣球導管Brosmed Medical Co., Ltd.
官方來源
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
廣告