Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200) → OWQ — Reprocessed Intravascular Ultrasound Catheter # OWQ · Reprocessed Intravascular Ultrasound Catheter _Cardiovascular · 21 CFR 870.1200 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ ## Overview - **Product Code:** OWQ - **Device Name:** Reprocessed Intravascular Ultrasound Catheter - **Regulation:** [21 CFR 870.1200](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1200) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) ## Identification An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others. ## Classification Rationale Class II (performance standards). ## Recent Cleared Devices (20 of 30) Showing 20 most recent of 30 cleared devices. | Record | Device Name | Applicant | Decision Date | Decision | | --- | --- | --- | --- | --- | | [K250545](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K250545.md) | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | Surgical Instrument Service and Savings, Inc. | Jun 5, 2025 | SESE | | [K250592](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K250592.md) | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. | May 12, 2025 | SESE | | [K243101](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K243101.md) | 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) | Surgical Instrument Service and Savings, Inc. | Mar 10, 2025 | SESE | | [K234064](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K234064.md) | 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) | Surgical Instrument Service and Savings, Inc. | Sep 10, 2024 | SESE | | [K232130](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K232130.md) | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | Dec 15, 2023 | SESE | | [K232584](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K232584.md) | 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 | Vein 360, LLC | Oct 24, 2023 | SESE | | [K230928](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K230928.md) | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | Aug 25, 2023 | SESE | | [K231621](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K231621.md) | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | Jul 25, 2023 | SESE | | [K231588](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K231588.md) | ViewFlex™ Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | Jun 30, 2023 | SESE | | [K230584](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K230584.md) | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | Jun 6, 2023 | SESE | | [K230934](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K230934.md) | ViewFlex™ Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | May 3, 2023 | SESE | | [K223026](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K223026.md) | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | Feb 3, 2023 | SESE | | [K222217](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K222217.md) | ViewFlex Xtra Reprocessed ICE Catheter | ABBOTT MEDICAL | Dec 19, 2022 | SESE | | [K210655](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K210655.md) | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Innovative Health, LLC | May 25, 2022 | SESE | | [K202042](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K202042.md) | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | Nov 20, 2020 | SESE | | [K190478](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K190478.md) | Reprocessed ViewFlex™ Xtra ICE Catheter | Sterilmed, Inc. | Nov 14, 2019 | SESE | | [K182238](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K182238.md) | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | May 8, 2019 | SESE | | [K181126](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K181126.md) | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | Jan 18, 2019 | SESE | | [K173262](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K173262.md) | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | Mar 6, 2018 | SESE | | [K163560](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ/K163560.md) | Reprocessed AcuNav Diagnostic Ultrasound Catheter | Innovative Health, LLC | Jul 12, 2017 | SESE | ## Top Applicants - Innovative Health, LLC — 7 clearances - Sterilmed, Inc. — 5 clearances - ABBOTT MEDICAL — 3 clearances - Surgical Instrument Service and Savings, Inc. — 3 clearances - Vein 360, LLC — 3 clearances --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/OWQ) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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