免責聲明: 本站彙整 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公開資料，僅供一般參考，不構成醫療建議、診斷、治療建議或投資建議。

FDA 510(k)

震波M5週邊內血管腔內碎石術（IVL）針管，內血管腔內碎石術（IVL）發生器及連接線，內血管腔內碎石術（IVL）連接線

K 號：K180958 · 2018-07-26

申請人Shockwave Medical, Inc.
決定日期2018-07-26
產品代碼PPN
諮詢委員會履歷
決定相當於

器材摘要

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable 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 2018-07-26 under 510(k) number K180958. 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 M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable?

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable is a medical device that received FDA 510(k) clearance on 2018-07-26. The listed applicant is Shockwave Medical, Inc.. The 510(k) number is K180958.

When did Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable receive FDA 510(k) clearance?

Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable received FDA 510(k) clearance on 2018-07-26, under 510(k) number K180958.

Who is the listed applicant for Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable?

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 M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable?

The FDA product code for Shockwave M5 Peripheral Intravascular Lithotripsy (IVL) Catheter, lntravascular Lithotripsy (IVL) Generator And Connector Cable, Intravascular Lithotripsy (IVL) Connector Cable is PPN.

相關臨床試驗

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。

NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

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。

↑