FDA 510(k)

Verge™ 微导管

K 號：K261610 · 2026-06-11

決定日期2026-06-11

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Verge™ 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 2026-06-11 under 510(k) number K261610. 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 Verge™ Microcatheter?

Verge™ Microcatheter is a medical device that received FDA 510(k) clearance on 2026-06-11. The listed applicant is Instylla, Inc.. The 510(k) number is K261610.

When did Verge™ Microcatheter receive FDA 510(k) clearance?

Verge™ Microcatheter received FDA 510(k) clearance on 2026-06-11, under 510(k) number K261610.

Who is the listed applicant for Verge™ 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 Verge™ Microcatheter?

The FDA product code for Verge™ 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。

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 K202544Instylla 輸送套件

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 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 K231821XO 心臟微導管（E20-090-S、E20-110-S、E20-130-S、E20-150-S、E20-175-S、E20-220-S、E20-090-B、E20-110-B、E20-130-B、E20-150-B、E20-175-B、E20-220-B、E26-090-S、E26-110-S、E26-130-S、E26-150-S、E26-175-S、E26-220-S、E26-090-B、E26-110-B、E26-130-B、E26-150-B、E26-175-B、E26-220-B）Transit Scientific, LLC

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。