FDA 510(k)

Pounce™ 套管

K 號：K231828 · 2023-09-07

決定日期2023-09-07

產品代碼DYB

諮詢委員會履歷

決定相當於

器材摘要

Pounce™ Sheath is the device name listed in this FDA 510(k) record. The listed applicant is Surmodics,Inc.. It received FDA 510(k) clearance on 2023-09-07 under 510(k) number K231828. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Pounce™ Sheath?

Pounce™ Sheath is a medical device that received FDA 510(k) clearance on 2023-09-07. The listed applicant is Surmodics,Inc.. The 510(k) number is K231828.

When did Pounce™ Sheath receive FDA 510(k) clearance?

Pounce™ Sheath received FDA 510(k) clearance on 2023-09-07, under 510(k) number K231828.

Who is the listed applicant for Pounce™ Sheath?

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™ Sheath?

The FDA product code for Pounce™ Sheath is DYB.

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 K241362Pounce XL 靈栓切除系統 (PTS-1011-7F135)K232647微導管 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：DYB）

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。

K253526NAMIC 扩張器及套管Medline Industries, LP K261529微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（SIS05C）；微穿刺套件 / 微穿刺接入套件 / 微穿刺導入器組 / 微導入器套件 / 微導入器套件（IS01）；導入器套件 / 微導入器套件 / 導入器組 / 微導入器組 / 微導入器鞘組 / 導入器鞘組（NIS04）Hartman Medical Group, LLC K261242簡易導引Pendracare K261950健康線拆離導入器Health Line International Corporation K261492FieldFlex 經導鞘CenterPoint Systems, LLC K260606回聲大內徑導入鞘Echo Medical, 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。