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FDA 510(k)

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip

K-Number: K160583 · 2016-10-26

ApplicantVolcano Corporation
Decision Date2016-10-26
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is a medical device manufactured by Volcano Corporation. It received FDA 510(k) clearance on 2016-10-26 under approval number K160583. 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 REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip?

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is a medical device that received FDA 510(k) clearance on 2016-10-26. It is manufactured by Volcano Corporation. The 510(k) number is K160583.

When was REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip approved by the FDA?

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip received FDA 510(k) clearance on 2016-10-26, under approval number K160583.

What company makes REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip?

REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is manufactured by Volcano Corporation.

What is the FDA product code for REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip?

The FDA product code for REFINITY Rotational IVUS Catheter, REFINITY Rotational IVUS Catheter, Short Tip is OBJ.

Related Clinical Trials

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Other Devices by Volcano Corporation

K161887Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-Tip K161756SyncVision System K172455CORE M2 Vascular System, CORE M2 Software v4.2 Upgrade Kit, CORE M2 Software v4.2 Installation Kit K172574SyncVision System K170385CORE M2 Vascular System K173860s5 Intravascular Ultrasound Imaging and Pressure Systems, s5i Intravascular Ultrasound Imaging and Pressure Systems, CORE Precision Guided Therapy System, CORE Mobile Precision Guided Therapy System

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Related Devices (Code: OBJ)

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 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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