FDA 510(k)

Bolt 體內輸尿管碎石術 (IVL) 系統

K 號：K250225 · 2025-03-25

決定日期2025-03-25

產品代碼PPN

諮詢委員會履歷

決定相當於

器材摘要

Bolt Intravascular Lithotripsy (IVL) System is the device name listed in this FDA 510(k) record. The listed applicant is Bolt Medical, Inc.. It received FDA 510(k) clearance on 2025-03-25 under 510(k) number K250225. The device is classified under product code PPN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Bolt Intravascular Lithotripsy (IVL) System?

Bolt Intravascular Lithotripsy (IVL) System is a medical device that received FDA 510(k) clearance on 2025-03-25. The listed applicant is Bolt Medical, Inc.. The 510(k) number is K250225.

When did Bolt Intravascular Lithotripsy (IVL) System receive FDA 510(k) clearance?

Bolt Intravascular Lithotripsy (IVL) System received FDA 510(k) clearance on 2025-03-25, under 510(k) number K250225.

Who is the listed applicant for Bolt Intravascular Lithotripsy (IVL) System?

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

What is the FDA product code for Bolt Intravascular Lithotripsy (IVL) System?

The FDA product code for Bolt Intravascular Lithotripsy (IVL) System is PPN.

其他以 Bolt Medical, 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。

K260246SEISMIQ™ 體內碎石系統

相關器械（代碼：PPN）

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。

官方來源

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