FDA 510(k)

HP PTA 擴張球囊心导管

K 號：K231402 · 2023-12-20

決定日期2023-12-20

產品代碼LIT

諮詢委員會履歷

決定相當於

器材摘要

HP PTA Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. It received FDA 510(k) clearance on 2023-12-20 under 510(k) number K231402. 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 HP PTA Balloon Dilatation Catheter?

HP PTA Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2023-12-20. The listed applicant is Kossel Medtech (Suzhou) Co., Ltd.. The 510(k) number is K231402.

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

HP PTA Balloon Dilatation Catheter received FDA 510(k) clearance on 2023-12-20, under 510(k) number K231402.

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

FDA 510(k) 記錄將科斯爾醫療技術（蘇州）有限公司列為申請人。這並不單獨確立設備製造商的身份。

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

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

其他以 Kossel Medtech (Suzhou) Co., 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。

K254212NC PTA 機械擴張導管 K221245PTA 機器擴張針管 K211349Selebrek PTCA 擴張球囊心导管 K211393Selethru™ NC PTCA 膨脹球擴張針管 K182699Selethru PTCA 擴張球囊心导管

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

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。