FDA 510(k)

Instylla 微导管

K 號：K191731 · 2019-08-13

決定日期2019-08-13

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Instylla Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Instylla, Inc.. It received FDA 510(k) clearance on 2019-08-13 under 510(k) number K191731. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Instylla Microcatheter?

Instylla Microcatheter is a medical device that received FDA 510(k) clearance on 2019-08-13. The listed applicant is Instylla, Inc.. The 510(k) number is K191731.

When did Instylla Microcatheter receive FDA 510(k) clearance?

Instylla Microcatheter received FDA 510(k) clearance on 2019-08-13, under 510(k) number K191731.

Who is the listed applicant for Instylla Microcatheter?

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

What is the FDA product code for Instylla Microcatheter?

The FDA product code for Instylla Microcatheter is KRA.

其他以 Instylla, Inc. 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。

K261610Verge™ 微导管 K253769Instylla 輸送套件 K253677坦博栓塞系統 K240873TEMBO 體內栓塊系統 K213632Instylla 輸送套件 K210808Instylla 微导管 1.2

查看所有 10 項裝置 →

相關器械（代碼：KRA）

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。

K253509TriSalus TriNav 先進輸液系統Trisalus Life Sciences K254051導入式輸液針管系統SmartWise Sweden AB K261610Verge™ 微导管Instylla, Inc.K260771TruSelect™ 2.6 微导管Boston Scientific Corporation K250794InVera 靜脈輸注設備Invera Medical K243534微導管Suzhou Zenith Vascular SciTech Limited

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。