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FDA 510(k)

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter

K-Number: K212959 · 2021-10-15

ApplicantSiemens Medical Solutions USA, Inc.
Decision Date2021-10-15
Product CodeOBJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter is a medical device manufactured by Siemens Medical Solutions USA, Inc.. It received FDA 510(k) clearance on 2021-10-15 under approval number K212959. 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(ICE) Catheter?

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter is a medical device that received FDA 510(k) clearance on 2021-10-15. It is manufactured by Siemens Medical Solutions USA, Inc.. The 510(k) number is K212959.

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

ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter received FDA 510(k) clearance on 2021-10-15, under approval number K212959.

What company makes ACUSON AcuNav Volume Intracardiac Echocardiography(ICE) Catheter?

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

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

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

Related Clinical Trials

NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING NCT06808217 A Registry on the FARAVIEW Technology of the OPAL HDx Mapping System When Used With the FARAWAVE NAV Ablation Catheter in the Treatment of Atrial Fibrillation ACTIVE_NOT_RECRUITING NCT07589452 Impact of Allometric Pacing Rate on Ventricular Diastolic Function and Cerebral Blood Flow in Hypertensive Patients With Sinus Node Dysfunction NOT_YET_RECRUITING NCT05054452 Predicting Fluid Responsiveness in Mechanically Ventilated Critically Ill Children Using Transthoracic Echocardiography COMPLETED NCT06011252 Pacing Characteristics of a Conventional Bipolar ACTIVE_NOT_RECRUITING NCT07583706 A Single-center, Single-arm Study to Evaluate the Safety and Efficacy of Ultra-minimally Invasive Prostate Dilation in Treating Patients With Significant Obstructive Symptoms Caused by Benign Prostatic Hyperplasia RECRUITING

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Related Devices (Code: OBJ)

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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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