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FDA 510(k)

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD

K-Number: K213593 · 2022-01-14

ApplicantBoston Scientific Corporation
Decision Date2022-01-14
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-01-14 under approval number K213593. 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, OptiCross HD, OptiCross 6, OptiCross 6 HD?

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD is a medical device that received FDA 510(k) clearance on 2022-01-14. It is manufactured by Boston Scientific Corporation. The 510(k) number is K213593.

When was OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD approved by the FDA?

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD received FDA 510(k) clearance on 2022-01-14, under approval number K213593.

What company makes OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD?

OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD is manufactured by Boston Scientific Corporation.

What is the FDA product code for OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD?

The FDA product code for OptiCross, OptiCross HD, OptiCross 6, OptiCross 6 HD 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 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. K173284OptiCross HD, 60 MHz Coronary Imaging Catheter (Paper DFU); OptiCross HD, 60 MHz Coronary Imaging Catheter (e-DFU)Boston Scientific Corporation

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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