FDA 510(k)

In-Ka 腎管氣球擴張針管

K 號：K201007 · 2020-06-11

決定日期2020-06-11

產品代碼EZN

諮詢委員會GU

決定Unknown

器材摘要

In-Ka Ureteral Balloon Dilatation Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Coloplast Corp.. It received FDA 510(k) clearance on 2020-06-11 under 510(k) number K201007. The device is classified under product code EZN. It was reviewed by the GU advisory panel. FDA Decision: Unknown.

常見問題

What is the In-Ka Ureteral Balloon Dilatation Catheter?

In-Ka Ureteral Balloon Dilatation Catheter is a medical device that received FDA 510(k) clearance on 2020-06-11. The listed applicant is Coloplast Corp.. The 510(k) number is K201007.

When did In-Ka Ureteral Balloon Dilatation Catheter receive FDA 510(k) clearance?

In-Ka Ureteral Balloon Dilatation Catheter received FDA 510(k) clearance on 2020-06-11, under 510(k) number K201007.

Who is the listed applicant for In-Ka Ureteral Balloon Dilatation Catheter?

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

What is the FDA product code for In-Ka Ureteral Balloon Dilatation Catheter?

The FDA product code for In-Ka Ureteral Balloon Dilatation Catheter is EZN.

其他以 Coloplast 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。

K252140嗨樂™ 系統 K251116盧雅曲線 K250270盧加設備 K242049SureCath 設備 K241210盧雅曲管 K242173重追溯輸尿管進入鞘（ASXL10、ASXL12、ACXL10、ACXL12、AXXL10、AXXL12、ALXL10、ALXL12）

查看所有 25 項裝置 →

相關器械（代碼：EZN）

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。

K250910Optilume® 高壓泌尿學氣球擴張導尿管Urotronic, Inc.K220781ARMADA Ureteral Dilator Set, ARMADA Nottingham One Step Dilator, ARMADA Amplatz Renal Dilator Sets, ARMADA Renal Dilator, Glider Amplatz Sheath, ARMADA Renal Dilator with Amplatz Sheath, Fascial Dilator Set, Introducer Sheath, Introducer CatheterAllwin Medical Devices, Inc.K190612EQUINOX 气球擴張導管Dornier Medtech America, Inc.K173654輸尿管擴張器組合，輸尿管擴張器Cook Incorporated K180756安全導絲導管Cook Incorporated K180028Cook 810 設備組，Desilets-Hoffman 引導器組Cook Incorporated

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。