FDA 510(k)

IceSeed 1.5 CX 90°針 (H7493967433170)；IceSeed 1.5 CX S 90°針 (H7493967233100)

K 號：K232635 · 2023-11-22

決定日期2023-11-22

產品代碼GEH

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific. It received FDA 510(k) clearance on 2023-11-22 under 510(k) number K232635. The device is classified under product code GEH. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is a medical device that received FDA 510(k) clearance on 2023-11-22. The listed applicant is Boston Scientific. The 510(k) number is K232635.

When did IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) receive FDA 510(k) clearance?

IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) received FDA 510(k) clearance on 2023-11-22, under 510(k) number K232635.

Who is the listed applicant for IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

FDA 510(k) 記錄將波士頓科學公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100)?

The FDA product code for IceSeed 1.5 CX 90º Needle (H7493967433170); IceSeed 1.5 CX S 90º Needle (H7493967233100) is GEH.

其他以 Boston Scientific 為申請人之記錄

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相關器械（代碼：GEH）

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。

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