FDA 510(k)

希望遠端進入導管

K 號：K231056 · 2024-03-08

決定日期2024-03-08

產品代碼QJP

諮詢委員會履歷

決定相當於

器材摘要

Esperance Distal Access 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 2024-03-08 under 510(k) number K231056. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Esperance Distal Access Catheter?

Esperance Distal Access Catheter is a medical device that received FDA 510(k) clearance on 2024-03-08. The listed applicant is Wallaby Medical. The 510(k) number is K231056.

When did Esperance Distal Access Catheter receive FDA 510(k) clearance?

Esperance Distal Access Catheter received FDA 510(k) clearance on 2024-03-08, under 510(k) number K231056.

Who is the listed applicant for Esperance Distal Access 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 Esperance Distal Access Catheter?

The FDA product code for Esperance Distal Access Catheter is QJP.

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 K232437Paragon 8F 气球導管 K223139烏鴉017微導管 K211697希望抽吸針系統

相關器械（代碼：QJP）

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。

K260220路92醫療全長046進入系統Route 92 Medical, Inc.K26227770 神經導引針管Piraeus Medical, Inc.K261176Zoom 4S 管針Imperative Care, Inc.K254071p17 XR 微导管Wallaby Medical K260199SLIM 微导管Balt USA, LLC K253901蟻蟻88 接通導管Perfuze, Ltd.

官方來源

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