FDA 510(k)

驚濤內血管結石破碎系統（IVL）搭配Javelin周邊內血管結石破碎（IVL）導管

K 號：K242213 · 2024-09-27

決定日期2024-09-27

產品代碼PPN

諮詢委員會履歷

決定相當於

器材摘要

Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Shockwave Medical, Inc.. It received FDA 510(k) clearance on 2024-09-27 under 510(k) number K242213. 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 Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter?

Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K242213.

When did Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter receive FDA 510(k) clearance?

Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter received FDA 510(k) clearance on 2024-09-27, under 510(k) number K242213.

Who is the listed applicant for Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter?

FDA 510(k) 記錄將 Shockwave 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 Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter?

The FDA product code for Shockwave Intravascular Lithotripsy (IVL) System with the Javelin Peripheral Intravascular Lithotripsy (IVL) Catheter is PPN.