FDA 510(k)

石子回收氣球導管

K 號：K210660 · 2021-04-27

決定日期2021-04-27

產品代碼GCA

諮詢委員會GU

決定相當於

器材摘要

Stone Retrieval Balloon Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. It received FDA 510(k) clearance on 2021-04-27 under 510(k) number K210660. The device is classified under product code GCA. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Stone Retrieval Balloon Catheter?

Stone Retrieval Balloon Catheter is a medical device that received FDA 510(k) clearance on 2021-04-27. The listed applicant is Anrei Medical (Hangzhou) Co., Ltd.. The 510(k) number is K210660.

When did Stone Retrieval Balloon Catheter receive FDA 510(k) clearance?

Stone Retrieval Balloon Catheter received FDA 510(k) clearance on 2021-04-27, under 510(k) number K210660.

Who is the listed applicant for Stone Retrieval Balloon Catheter?

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

What is the FDA product code for Stone Retrieval Balloon Catheter?

The FDA product code for Stone Retrieval Balloon Catheter is GCA.

其他以 Anrei Medical (Hangzhou) 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。

K212999多功能電外科刀 K210917單次使用注射針 K202987救援肺抓取镊子 K201771單次使用可旋轉及可重置式血液夾 K192048單次使用內視鏡閥門組

相關器械（代碼：GCA）

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。

K253013一次性石塊回收氣球導管Zhejiang Soudon Medical Technology Co., Ltd.K232752石頭提取氣球（VDK-BAL-23-11/13/15-B，VDK-BAL-23-15/18/20-B，VDK-BAL-23-9/12/15-B，VDK-BAL-23-10/13/16-B，VDK-BAL-23-8.5/11.5/15-B，VDK-BAL-23-12/15/18-B，VDK-BAL-23-11/13/15-C，VDK-BAL-23-15/18/20-C，VDK-BAL-23-9/12/15-C，VDK-BAL-23-10/13/16-C，VDK-BAL-23-8.5/11.5/15-C，VDK-BAL-23-12/15/18-C）Jiangsu Vedkang Medical Science and Technology Co., Ltd.K212582SpyGlass Discover 激光擴張導管Boston Scientific Corporation K200173石子回收氣球Hangzhou AGS MedTech Co., Ltd.K200247融合四合一抽吸球Wilson-Cook Medical, Inc.K193344三重抽離氣球，多尺寸設計Wilson-Cook Medical, 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。