Product Code: OWQ FDA class 2 21 CFR 870.1200

Reprocessed Intravascular Ultrasound Catheter

Cardiovascular

The Reprocessed Intravascular Ultrasound Catheter is a reprocessed cardiovascular device used for intracardiac and intraluminal visualization of cardiovascular anatomy and physiology. It is classified as Class 2 (FDA Class 2), requiring 510(k) premarket clearance. The product code is OWQ, with regulation number 870.1200 under the Cardiovascular medical specialty.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

Years Active

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Basic Information

Product Code: OWQ
Device Class: FDA class 2
Regulation Number: 870.1200
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

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Summary Malfunction Reporting

Definition

For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 30 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K250545	Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG)	Jun 05, 2025	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K250592	NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)	May 12, 2025	Substantially Equivalent	Northeast Scientific, Inc.
K243101	Medline 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)	Mar 10, 2025	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K234064	Medline 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)	Sep 10, 2024	Substantially Equivalent	Surgical Instrument Service and Savings, Inc.
K232130	Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter	Dec 15, 2023	Substantially Equivalent	Surgical Instrument Services and Savings, Inc.
K232584	Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter	Oct 24, 2023	Substantially Equivalent	Vein 360, LLC
K230928	Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter	Aug 25, 2023	Substantially Equivalent	Vein 360, LLC
K231621	Reprocessed ViewFlex Xtra ICE Catheter (D087031)	Jul 25, 2023	Substantially Equivalent	Stryker Sustainability Solutions
K231588	ViewFlex Eco Reprocessed ICE Catheter	Jun 30, 2023	Substantially Equivalent	ABBOTT MEDICAL
K230584	Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter	Jun 06, 2023	Substantially Equivalent	Vein 360, LLC
K230934	ViewFlex Eco Reprocessed ICE Catheter	May 03, 2023	Substantially Equivalent	ABBOTT MEDICAL
K223026	NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter	Feb 03, 2023	Substantially Equivalent	Northeast Scientific, Inc.
K222217	ViewFlex Xtra Reprocessed ICE Catheter	Dec 19, 2022	Substantially Equivalent	ABBOTT MEDICAL
K210655	Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter	May 25, 2022	Substantially Equivalent	Innovative Health, LLC
K202042	Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter	Nov 20, 2020	Substantially Equivalent	Innovative Health, LLC
K190478	Reprocessed ViewFlex Xtra ICE Catheter	Nov 14, 2019	Substantially Equivalent	Sterilmed, Inc.
K182238	Reprocessed ViewFlex Xtra ICE Catheter	May 08, 2019	Substantially Equivalent	Stryker Sustainability Solutions
K181126	Reprocessed Visions PV .035 Digital IVUS Catheter	Jan 18, 2019	Substantially Equivalent	Innovative Health, LLC
K173262	Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter	Mar 06, 2018	Substantially Equivalent	Innovative Health, LLC
K163560	Reprocessed AcuNav Diagnostic Ultrasound Catheter	Jul 12, 2017	Substantially Equivalent	Innovative Health, LLC
K170474	Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter	Jun 16, 2017	Substantially Equivalent	Innovative Health, LLC
K161700	SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters	Nov 21, 2016	Substantially Equivalent	Sterilmed, Inc.
K153090	Reprocessed Diagnostic Ultrasound Catheter	Mar 10, 2016	Substantially Equivalent	Innovative Health, LLC
K121913	REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER	Dec 20, 2012	Substantially Equivalent	Stryker Sustainability Solutions, Inc.
K110076	REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER	Aug 18, 2011	Substantially Equivalent	Sterilmed, Inc.
K092425	REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10	Oct 21, 2009	Substantially Equivalent	Ascent Healthcare Solutions
K063076	REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER	Mar 29, 2007	Substantially Equivalent	Ascent Healthcare Solutions
K033436	REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER	Mar 16, 2005	Substantially Equivalent	Alliance Medical Corp.
K043453	STERILEMED REPROCESSED IVUS IMAGING CATHETER	Mar 01, 2005	Substantially Equivalent	Sterilmed, Inc.
K012537	REPROCESSED IMAGING CATHETERS	Oct 11, 2002	Substantially Equivalent	Sterilmed, Inc.