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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 the device name listed in this FDA 510(k) record. The listed applicant is Innovative Health, LLC. It received FDA 510(k) clearance on 2017-06-16 under 510(k) 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. The listed applicant is Innovative Health, LLC. The 510(k) number is K170474.

When did Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter receive FDA 510(k) clearance?

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

Who is the listed applicant for Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter?

The FDA 510(k) record lists Innovative Health, LLC as the applicant. This does not by itself establish the device manufacturer.

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

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06556836"Diagnostic Accuracy of Ultrasound Compared to Epidurography for Epidural Catheter Localization"COMPLETEDNCT07629427Green or Pink? A Comparison of Pain and Procedural Difficulty With Intravenous Cannulas in the Emergency DepartmentCOMPLETEDNCT07779317Single Lumen Midline Catheter vs Ultrasound Guided Peripheral IV as Performed by Bedside Emergency Department Registered NursesRECRUITING

Other records listing Innovative Health, LLC as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250305Reprocessed Agilis NxT Steerable IntroducerK231015Reprocessed Super Torque and Super Torque Plus Diagnostic Angiographic CathetersK233825Reprocessed Webster Duo-Decapolar Diagnostic EP CatheterK232037Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding SheathK230376Reprocessed Agilis NxT Steerable IntroducerK213584Reprocessed NRG Transseptal Needle

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Related Devices (Code: OWQ)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254149Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL™ Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485)Sterilmed, Inc.K250545Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)Surgical Instrument Service and Savings, Inc.K250592NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)Northeast Scientific, Inc.K243101Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for GE Systems) (10043342)Surgical Instrument Service and Savings, Inc.K234064Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for GE Systems) (10135910)Surgical Instrument Service and Savings, Inc.K232130Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterSurgical Instrument Services and Savings, 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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