FDA 510(k)

Pounce XL 靈栓切除系統 (PTS-1011-7F135)

K 號：K241362 · 2024-09-11

決定日期2024-09-11

產品代碼QEW

諮詢委員會履歷

決定相當於

器材摘要

Pounce XL Thrombectomy System (PTS-1011-7F135) is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2024-09-11 under 510(k) number K241362. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pounce XL Thrombectomy System (PTS-1011-7F135)?

Pounce XL Thrombectomy System (PTS-1011-7F135) is a medical device that received FDA 510(k) clearance on 2024-09-11. The listed applicant is Surmodics,Inc.. The 510(k) number is K241362.

When did Pounce XL Thrombectomy System (PTS-1011-7F135) receive FDA 510(k) clearance?

Pounce XL Thrombectomy System (PTS-1011-7F135) received FDA 510(k) clearance on 2024-09-11, under 510(k) number K241362.

Who is the listed applicant for Pounce XL Thrombectomy System (PTS-1011-7F135)?

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

What is the FDA product code for Pounce XL Thrombectomy System (PTS-1011-7F135)?

The FDA product code for Pounce XL Thrombectomy System (PTS-1011-7F135) is QEW.

其他以 Surmodics,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。

K252227Pounce™ 套管 K232647微導管 K231828Pounce™ 套管 K231022Pounce™ 靈活血栓切除系統 K221886優雅微導管 K220501Pounce 靈活血栓切除系統

查看所有 11 項裝置 →

相關器械（代碼：QEW）

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。

K253419Triever Duo 穿刺針管Inari Medical, Inc.K261800Helo Max 靈栓切除系統 (HEL2090)Endovascular Engineering K262538Artix™ MT;Artix™ Thin-Walled SheathInari Medical, Inc.K261523Vertex™ 靈栓切除系統Jupiter Endovascular K260599INDIGO® 吸引系統 – INDIGO 鏈接Penumbra, Inc.K251949INDIGO® 吸引系統 - 雷電閃吸管連結版Penumbra, 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。