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FDA 510(k)

OptiCross X, 40 MHz Coronary Imaging Catheter

K-Number: K161125 · 2016-05-19

ApplicantBoston Scientific Corporation
Decision Date2016-05-19
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiCross X, 40 MHz Coronary Imaging Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2016-05-19 under approval 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. It is manufactured by Boston Scientific Corporation. The 510(k) number is K161125.

When was OptiCross X, 40 MHz Coronary Imaging Catheter approved by the FDA?

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

What company makes OptiCross X, 40 MHz Coronary Imaging Catheter?

OptiCross X, 40 MHz Coronary Imaging Catheter is manufactured by Boston Scientific Corporation.

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)

K160583REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short TipVolcano Corporation K160514OptiCross 18, 30 MHz Peripheral Imaging CatheterBoston Scientific Corporation K153617OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution)Boston Scientific Corporation K173618ACUSON AcuNav Volume Intracardiac Echocardiography CatheterSiemens Medical Solutions USA, Inc. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation K173063ACIST Kodama Intravascular Ultrasound Catheter, ACIST HDi SystemAcist Medical Systems, Inc.

Official Source

View on FDA Database →

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

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