FDA 510(k)

OptiCross X, 40 MHz Coronary Imaging Catheter

K-Number: K161125 · 2016-05-19

Decision Date2016-05-19

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OptiCross X, 40 MHz Coronary Imaging Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-05-19 under 510(k) number K161125. The device is classified under product code OBJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiCross X, 40 MHz Coronary Imaging Catheter?

OptiCross X, 40 MHz Coronary Imaging Catheter is a medical device that received FDA 510(k) clearance on 2016-05-19. The listed applicant is Boston Scientific Corporation. The 510(k) number is K161125.

When did OptiCross X, 40 MHz Coronary Imaging Catheter receive FDA 510(k) clearance?

OptiCross X, 40 MHz Coronary Imaging Catheter received FDA 510(k) clearance on 2016-05-19, under 510(k) number K161125.

Who is the listed applicant for OptiCross X, 40 MHz Coronary Imaging Catheter?

The FDA 510(k) record lists Boston Scientific Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OptiCross X, 40 MHz Coronary Imaging Catheter?

The FDA product code for OptiCross X, 40 MHz Coronary Imaging Catheter is OBJ.

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Related Devices (Code: OBJ)

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.K250913TINGSN FINDERS 2 Color Doppler Diagnostic Ultrasound SystemJiangsu Tingsn Technology Co., Ltd.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.