FDA 510(k)

震波醫療週邊內血管腔內碎石術（IVL）系統

K 號：K221041 · 2022-04-25

決定日期2022-04-25

產品代碼PPN

諮詢委員會履歷

決定相當於

器材摘要

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System 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 2022-04-25 under 510(k) number K221041. 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 Medical Peripheral Intravascular Lithotripsy (IVL) System?

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is a medical device that received FDA 510(k) clearance on 2022-04-25. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K221041.

When did Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System receive FDA 510(k) clearance?

Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System received FDA 510(k) clearance on 2022-04-25, under 510(k) number K221041.

Who is the listed applicant for Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System?

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 Medical Peripheral Intravascular Lithotripsy (IVL) System?

The FDA product code for Shockwave Medical Peripheral Intravascular Lithotripsy (IVL) System is PPN.

其他以 Shockwave 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。

K262201驚濤內血管結石破碎系統，配備驚濤E8周邊內血管結石破碎導管 K243757驚波CS導管導引針 K242213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 K240954驚濤內血管結石破碎系統，配備驚濤L6周邊內血管結石破碎導管 K240225驚濤內血管結石破碎系統，配備驚濤E8周邊內血管結石破碎導管 K221852驚濤內血管結石破碎系統，配備驚濤L6周邊內血管結石破碎導管

查看所有 13 項裝置 →

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。

K260246SEISMIQ™ 體內碎石系統Bolt Medical, Inc.K262201驚濤內血管結石破碎系統，配備驚濤E8周邊內血管結石破碎導管Shockwave Medical, Inc.K250225Bolt 體內輸尿管碎石術 (IVL) 系統Bolt Medical, Inc.K242213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Shockwave Medical, Inc.K240954驚濤內血管結石破碎系統，配備驚濤L6周邊內血管結石破碎導管Shockwave Medical, Inc.K240225驚濤內血管結石破碎系統，配備驚濤E8周邊內血管結石破碎導管Shockwave Medical, 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。