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FDA 510(k)

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter

K-Number: K170474 · 2017-06-16

ApplicantInnovative Health, LLC
Decision Date2017-06-16
Product CodeOWQ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2017-06-16 under approval number K170474. The device is classified under product code OWQ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter?

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is a medical device that received FDA 510(k) clearance on 2017-06-16. It is manufactured by Innovative Health, LLC. The 510(k) number is K170474.

When was Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter approved by the FDA?

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter received FDA 510(k) clearance on 2017-06-16, under approval number K170474.

What company makes Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter?

Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter?

The FDA product code for Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter is OWQ.

Related Clinical Trials

NCT07040696 Accuracy of Venous Excess Ultrasound Score at Hospital Admission to Predict Acute Kidney Injury COMPLETED NCT06958731 In-plane Versus Real Time Bi-plane Single-operator Laser-assisted With a Innovative T-shaped Probe for Ultrasound-guided Internal Jugular Vein Catheterization:A Randomized Controlled Trial ENROLLING_BY_INVITATION NCT05857852 Low-Intensity Focused Ultrasound for Cocaine Use Disorder COMPLETED NCT07095660 RECANA OUS - Recana Thrombectomy Catheter System for Venous Obstruction and Occlusion Study (RECANA-OUS-IRL) RECRUITING NCT06253858 Ultrasound (US) Guided External Ventricular Catheter Placement RECRUITING NCT07552272 Hummingbird ICE Study NOT_YET_RECRUITING

Other Devices by Innovative Health, LLC

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Related Devices (Code: OWQ)

K161700SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound CathetersSterilmed, Inc. K153090Reprocessed Diagnostic Ultrasound CatheterInnovative Health, LLC K163560Reprocessed AcuNav Diagnostic Ultrasound CatheterInnovative Health, LLC K173262Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound CatheterInnovative Health, LLC K190478Reprocessed ViewFlex™ Xtra ICE CatheterSterilmed, Inc. K182238Reprocessed ViewFlex Xtra ICE CatheterStryker Sustainability Solutions

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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