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FDA 510(k)

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)

K-Number: K173284 · 2017-11-16

ApplicantBoston Scientific Corporation
Decision Date2017-11-16
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2017-11-16 under approval number K173284. 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 HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)?

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) is a medical device that received FDA 510(k) clearance on 2017-11-16. It is manufactured by Boston Scientific Corporation. The 510(k) number is K173284.

When was OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) approved by the FDA?

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) received FDA 510(k) clearance on 2017-11-16, under approval number K173284.

What company makes OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)?

OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) is manufactured by Boston Scientific Corporation.

What is the FDA product code for OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)?

The FDA product code for OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU) is OBJ.

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Related PubMed Literature

PMID: 41448934 [Regulatory Practices and Implications of FDA Approving New Drug Indication under the Medical Device Pathway]. Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2025)

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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 K161125OptiCross X, 40 MHz Coronary 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. 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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