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FDA 510(k)

AcuNav Crystal Ultrasound Catheter

K-Number: K233270 · 2023-10-28

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2023-10-28
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AcuNav Crystal Ultrasound Catheter is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2023-10-28 under approval number K233270. 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 AcuNav Crystal Ultrasound Catheter?

AcuNav Crystal Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2023-10-28. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K233270.

When was AcuNav Crystal Ultrasound Catheter approved by the FDA?

AcuNav Crystal Ultrasound Catheter received FDA 510(k) clearance on 2023-10-28, under approval number K233270.

What company makes AcuNav Crystal Ultrasound Catheter?

AcuNav Crystal Ultrasound Catheter is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for AcuNav Crystal Ultrasound Catheter?

The FDA product code for AcuNav Crystal Ultrasound 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

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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