FDA 510(k)

Reconnaissance PV .018 OTW 디지털 IVUS 캐터터

K-번호: K200410 · 2020-05-22

신청자Philips Image Guided Therapy Corporation

결정일2020-05-22

제품 코드OBJ

자문 위원회CV

결정Substantially Equivalent

기기 요약

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.

자주 묻는 질문

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.

Philips Image Guided Therapy Corporation를 신청인으로 등재한 기타 기록

K253714IntraSight Plus K251103VeriSight Intracardiac Echocardiography Catheter (VSICE2D); VeriSight Pro Intracardiac Echocardiography Catheter (VSICE3D)K200812VeriSight Intracardiac Echocardiography (ICE) Catheter, VeriSight Pro ICE Catheter

관련 기기 (코드: OBJ)

K261696ACUNAV Luxera 4D ICE CatheterSiemens Medical Solutions USA, Inc.K261849VERAFEYE Imaging Catheter (VF-VIC-002)Luma Vision Limited K252945Novasight Hybrid SystemConavi Medical, Inc.K260816OptiCross Coronary Imaging Catheter (H749518110); OptiCross 6 Coronary Imaging Catheter (H7495181160); OptiCross HD Coronary Imaging Catheter (H74939352040); OptiCross 6 HD Coronary Imaging Catheter (H74939354080); OptiCross Coronary Imaging Catheter (Bagless) (H749518130); OptiCross 6 Coronary Imaging Catheter (Bagless) (H7495181360); OptiCross HD Coronary Imaging Catheter (Bagless) (H74939352050); OptiCross 6 HD Coronary Imaging Catheter (Bagless) (H74939354090)Boston Scientific K253399Visions® PV .014P RX Digital IVUS Catheter ; Visions® PV .018 Digital IVUS CatheterVolcano Corporation (Dba Philips Image Guided Therapy Device K250955XC11 ICE System, USAYorlabs, Inc.

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