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FDA 510(k)

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter

K-Number: K173618 · 2017-12-19

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2017-12-19
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2017-12-19 under approval number K173618. 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 ACUSON AcuNav Volume Intracardiac Echocardiography Catheter?

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter is a medical device that received FDA 510(k) clearance on 2017-12-19. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K173618.

When was ACUSON AcuNav Volume Intracardiac Echocardiography Catheter approved by the FDA?

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter received FDA 510(k) clearance on 2017-12-19, under approval number K173618.

What company makes ACUSON AcuNav Volume Intracardiac Echocardiography Catheter?

ACUSON AcuNav Volume Intracardiac Echocardiography Catheter is manufactured by Siemens Medical Solutions USA, Inc..

What is the FDA product code for ACUSON AcuNav Volume Intracardiac Echocardiography Catheter?

The FDA product code for ACUSON AcuNav Volume Intracardiac Echocardiography Catheter is OBJ.

Related Clinical Trials

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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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