Panels › Cardiovascular › Product code OWQ · Class 2
Reprocessed Intravascular Ultrasound Catheter
Regulation 870.1200
1510(k)s in 12 months (31 all time)
5recalls in 12 months (10 all time)
9recalls that name a 510(k)
Top companies in OWQ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 29, 2026 | K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CR Sterilmed, Inc. | OWQ |
| Jun 5, 2025 | K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) Surgical Instrument Service and Savings, Inc. | OWQ |
| May 12, 2025 | K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) Northeast Scientific, Inc. | OWQ |
| Mar 10, 2025 | K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens Systems) (08255790 ); Medline ReN Surgical Instrument Service and Savings, Inc. | OWQ |
| Sep 10, 2024 | K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens Systems) (10135936); Medline ReNew Surgical Instrument Service and Savings, Inc. | OWQ |
| Dec 15, 2023 | K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter Surgical Instrument Services and Savings, Inc. | OWQ |
| Oct 24, 2023 | K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Cat Vein 360, LLC | OWQ |
| Aug 25, 2023 | K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter Vein 360, LLC | OWQ |
| Jul 25, 2023 | K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) Stryker Sustainability Solutions | OWQ |
| Jun 30, 2023 | K231588 | ViewFlex Eco Reprocessed ICE Catheter ABBOTT MEDICAL | OWQ |
| Jun 6, 2023 | K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter Vein 360, LLC | OWQ |
| May 3, 2023 | K230934 | ViewFlex Eco Reprocessed ICE Catheter ABBOTT MEDICAL | OWQ |
| Feb 3, 2023 | K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Northeast Scientific, Inc. | OWQ |
| Dec 19, 2022 | K222217 | ViewFlex Xtra Reprocessed ICE Catheter ABBOTT MEDICAL | OWQ |
| May 25, 2022 | K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter Innovative Health, LLC | OWQ |
| Nov 20, 2020 | K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Nov 14, 2019 | K190478 | Reprocessed ViewFlex Xtra ICE Catheter Sterilmed, Inc. | OWQ |
| May 8, 2019 | K182238 | Reprocessed ViewFlex Xtra ICE Catheter Stryker Sustainability Solutions | OWQ |
| Jan 18, 2019 | K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter Innovative Health, LLC | OWQ |
| Mar 6, 2018 | K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Jul 12, 2017 | K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Jun 16, 2017 | K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Nov 21, 2016 | K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters Sterilmed, Inc. | OWQ |
| Mar 10, 2016 | K153090 | Reprocessed Diagnostic Ultrasound Catheter Innovative Health, LLC | OWQ |
| Dec 20, 2012 | K121913 | REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER Stryker Sustainability Solutions, Inc. | OWQ |
| Aug 18, 2011 | K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER Sterilmed, Inc. | OWQ |
| Oct 21, 2009 | K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 Ascent Healthcare Solutions | OWQ |
| Mar 29, 2007 | K063076 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER Ascent Healthcare Solutions | OWQ |
| Mar 16, 2005 | K033436 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER Alliance Medical Corp. | OWQ |
| Mar 1, 2005 | K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER Sterilmed, Inc. | OWQ |
| Oct 11, 2002 | K012537 | REPROCESSED IMAGING CATHETERS Sterilmed, Inc. | OWQ |
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