FDA 510(k)

Reconnaissance PV .018 OTW Digital IVUS Catheter

K 號：K200410 · 2020-05-22

申請人Philips Image Guided Therapy Corporation

決定日期2020-05-22

產品代碼OBJ

諮詢委員會履歷

決定相當於

器材摘要

Reconnaissance PV .018 OTW Digital IVUS Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Philips Image Guided Therapy Corporation. It received FDA 510(k) clearance on 2020-05-22 under 510(k) number K200410. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Reconnaissance PV .018 OTW Digital IVUS Catheter?

Reconnaissance PV .018 OTW Digital IVUS Catheter is a medical device that received FDA 510(k) clearance on 2020-05-22. The listed applicant is Philips Image Guided Therapy Corporation. The 510(k) number is K200410.

When did Reconnaissance PV .018 OTW Digital IVUS Catheter receive FDA 510(k) clearance?

Reconnaissance PV .018 OTW Digital IVUS Catheter received FDA 510(k) clearance on 2020-05-22, under 510(k) number K200410.

Who is the listed applicant for Reconnaissance PV .018 OTW Digital IVUS Catheter?

The FDA 510(k) record lists Philips Image Guided Therapy Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Reconnaissance PV .018 OTW Digital IVUS Catheter?

The FDA product code for Reconnaissance PV .018 OTW Digital IVUS Catheter is OBJ.

其他以 Philips Image Guided Therapy Corporation 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。

K253714IntraSight Plus K251103VeriSight 心內超聲心臟內穿刺針 (VSICE2D)；VeriSight Pro 心內超聲心臟內穿刺針 (VSICE3D)K200812VeriSight 心內超聲內心臟內心導管，VeriSight Pro 心內超聲內心臟內心導管

相關器械（代碼：OBJ）

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

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。