FDA 510(k)

驚濤內血管結石破碎系統，配備驚濤M5+周邊內血管結石破碎導管

K 號：K203365 · 2021-04-22

決定日期2021-04-22

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 Shockwave M5+ Peripheral 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 2021-04-22 under 510(k) number K203365. 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 Shockwave M5+ Peripheral IVL Catheter?

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter is a medical device that received FDA 510(k) clearance on 2021-04-22. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K203365.

When did Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter receive FDA 510(k) clearance?

Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter received FDA 510(k) clearance on 2021-04-22, under 510(k) number K203365.

Who is the listed applicant for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral 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 Shockwave M5+ Peripheral IVL Catheter?

The FDA product code for Shockwave Intravascular Lithotripsy (IVL) System with the Shockwave M5+ Peripheral IVL Catheter 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

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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

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