FDA 510(k)

OptiCross 18 Peripheral Imaging Catheter

K-Number: K222568 · 2022-09-23

Decision Date2022-09-23

Product CodeOBJ

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

OptiCross 18 Peripheral Imaging Catheter is a medical device manufactured by Boston Scientific Corporation. It received FDA 510(k) clearance on 2022-09-23 under approval number K222568. 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 18 Peripheral Imaging Catheter?

OptiCross 18 Peripheral Imaging Catheter is a medical device that received FDA 510(k) clearance on 2022-09-23. It is manufactured by Boston Scientific Corporation. The 510(k) number is K222568.

When was OptiCross 18 Peripheral Imaging Catheter approved by the FDA?

OptiCross 18 Peripheral Imaging Catheter received FDA 510(k) clearance on 2022-09-23, under approval number K222568.

What company makes OptiCross 18 Peripheral Imaging Catheter?

OptiCross 18 Peripheral Imaging Catheter is manufactured by Boston Scientific Corporation.

What is the FDA product code for OptiCross 18 Peripheral Imaging Catheter?

The FDA product code for OptiCross 18 Peripheral 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 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

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