OWQ · Reprocessed Intravascular Ultrasound Catheter
Cardiovascular · 21 CFR 870.1200 · Class 2
Overview
| Product Code | OWQ |
|---|---|
| Device Name | Reprocessed Intravascular Ultrasound Catheter |
| Regulation | 21 CFR 870.1200 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
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 | 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 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. | May 12, 2025 | SESE |
| 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) | Surgical Instrument Service and Savings, Inc. | Mar 10, 2025 | SESE |
| 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) | Surgical Instrument Service and Savings, Inc. | Sep 10, 2024 | SESE |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | Dec 15, 2023 | SESE |
| 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 | Vein 360, LLC | Oct 24, 2023 | SESE |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | Aug 25, 2023 | SESE |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | Jul 25, 2023 | SESE |
| K231588 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | Jun 30, 2023 | SESE |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | Jun 6, 2023 | SESE |
| K230934 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | May 3, 2023 | SESE |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | Feb 3, 2023 | SESE |
| K222217 | ViewFlex Xtra Reprocessed ICE Catheter | ABBOTT MEDICAL | Dec 19, 2022 | SESE |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Innovative Health, LLC | May 25, 2022 | SESE |
| K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | Nov 20, 2020 | SESE |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | Sterilmed, Inc. | Nov 14, 2019 | SESE |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | May 8, 2019 | SESE |
| K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | Jan 18, 2019 | SESE |
| K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | Mar 6, 2018 | SESE |
| K163560 | 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
