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FDA 510(k)

SABER .014 PTA 膨脹導管；SABERX .014 PTA 膨脹導管

K 號：K221832 · 2022-08-22

申請人Cordis US Corp
決定日期2022-08-22
產品代碼LIT
諮詢委員會履歷
決定相當於

器材摘要

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Cordis US Corp. It received FDA 510(k) clearance on 2022-08-22 under 510(k) number K221832. 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 SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2022-08-22. The listed applicant is Cordis US Corp. The 510(k) number is K221832.

When did SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter receive FDA 510(k) clearance?

SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter received FDA 510(k) clearance on 2022-08-22, under 510(k) number K221832.

Who is the listed applicant for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

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

What is the FDA product code for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter?

The FDA product code for SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation 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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Cordis US Corp 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。

K233637Cordis BRITECROSS 支援導管K232573INFINITI™ 雙向顯影導管K230704RAIN Sheath™ 靈骨腳導入器

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 AGK252512Armada™ 14 NC PTA 穿刺導管ABBOTT MEDICALK251915Amethyst 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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