FDA 510(k)

烏鴉017微導管

K 號：K223139 · 2023-04-25

決定日期2023-04-25

產品代碼KRA

諮詢委員會履歷

決定相當於

器材摘要

Wallaby 017 Micro Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Wallaby Medical. It received FDA 510(k) clearance on 2023-04-25 under 510(k) number K223139. 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 Wallaby 017 Micro Catheter?

Wallaby 017 Micro Catheter is a medical device that received FDA 510(k) clearance on 2023-04-25. The listed applicant is Wallaby Medical. The 510(k) number is K223139.

When did Wallaby 017 Micro Catheter receive FDA 510(k) clearance?

Wallaby 017 Micro Catheter received FDA 510(k) clearance on 2023-04-25, under 510(k) number K223139.

Who is the listed applicant for Wallaby 017 Micro Catheter?

FDA 510(k) 記錄將 Wallaby Medical 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Wallaby 017 Micro Catheter?

The FDA product code for Wallaby 017 Micro Catheter is KRA.

其他以 Wallaby Medical 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。

K254071p17 XR 微导管 K240917Esperance 3+ 吸引針系統 K231056希望遠端進入導管 K232437Paragon 8F 气球導管 K211697希望抽吸針系統

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

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