FDA 510(k) Applications for Medical Device Product Code "OWQ"
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K222217 | Abbott Medical | ViewFlex Xtra Reprocessed ICE Catheter | 12/19/2022 |
| K230934 | Abbott Medical | ViewFlexÖ Eco Reprocessed ICE Catheter | 05/03/2023 |
| K231588 | Abbott Medical | ViewFlexÖ Eco Reprocessed ICE Catheter | 06/30/2023 |
| K033436 | ALLIANCE MEDICAL CORP. | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | 03/16/2005 |
| K092425 | ASCENT HEALTHCARE SOLUTIONS | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | 10/21/2009 |
| K063076 | ASCENT HEALTHCARE SOLUTIONS | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | 03/29/2007 |
| K153090 | INNOVATIVE HEALTH, LLC | Reprocessed Diagnostic Ultrasound Catheter | 03/10/2016 |
| K181126 | Innovative Health, LLC | Reprocessed Visions PV .035 Digital IVUS Catheter | 01/18/2019 |
| K163560 | Innovative Health, LLC. | Reprocessed AcuNav Diagnostic Ultrasound Catheter | 07/12/2017 |
| K210655 | Innovative Health, LLC. | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | 05/25/2022 |
| K170474 | Innovative Health, LLC. | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | 06/16/2017 |
| K173262 | Innovative Health, Llc. | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | 03/06/2018 |
| K202042 | Innovative Health, LLC. | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | 11/20/2020 |
| K223026 | Northeast Scientific, Inc. | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | 02/03/2023 |
| K250592 | Northeast Scientific, Inc. | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | 05/12/2025 |
| K110076 | STERILMED, INC. | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER | 08/18/2011 |
| K012537 | STERILMED, INC. | REPROCESSED IMAGING CATHETERS | 10/11/2002 |
| K190478 | Sterilmed, Inc. | Reprocessed ViewFlexÖ Xtra ICE Catheter | 11/14/2019 |
| K161700 | STERILMED, INC. | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | 11/21/2016 |
| K043453 | STERILMED, INC. | STERILEMED REPROCESSED IVUS IMAGING CATHETER | 03/01/2005 |
| K182238 | Stryker Sustainability Solutions | Reprocessed ViewFlex Xtra ICE Catheter | 05/08/2019 |
| K231621 | Stryker Sustainability Solutions | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | 07/25/2023 |
| K121913 | STRYKER SUSTAINABILITY SOLUTIONS, INC. | REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER | 12/20/2012 |
| K250545 | Surgical Instrument Service and Savings Inc. | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | 06/05/2025 |
| K243101 | Surgical Instrument Service and Savings Inc. | 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) | 03/10/2025 |
| K234064 | Surgical Instrument Service and Savings Inc. | 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) | 09/10/2024 |
| K232130 | Surgical Instrument Services and Savings, Inc | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | 12/15/2023 |
| K232584 | Vein 360 LLC | 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 | 10/24/2023 |
| K230928 | Vein 360 LLC | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | 08/25/2023 |
| K230584 | Vein 360 LLC | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | 06/06/2023 |
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