FDA Product Code
FDA Product Code OWQ — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Cardiovascular
- 21 CFR Citation
- 870.1200
510(k) Clearances — 31 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510825); Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657484); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System (R11510826); Reprocessed SOUNDSTAR CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on GE System (R11657485) | Sterilmed, Inc. | 2026-06-29 | Traditional | PDF ↗ |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound Catheter (8F, 8FG, 10F, 10FG) | Surgical Instrument Service and Savings, Inc. | 2025-06-05 | Traditional | PDF ↗ |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | Northeast Scientific, Inc. | 2025-05-12 | Traditional | PDF ↗ |
| 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. | 2025-03-10 | Traditional | PDF ↗ |
| 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. | 2024-09-10 | Traditional | PDF ↗ |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | Surgical Instrument Services and Savings, Inc. | 2023-12-15 | Traditional | PDF ↗ |
| 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 | 2023-10-24 | Traditional | PDF ↗ |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | 2023-08-25 | Traditional | PDF ↗ |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | Stryker Sustainability Solutions | 2023-07-25 | Special | PDF ↗ |
| K231588 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | 2023-06-30 | Special | PDF ↗ |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | 2023-06-06 | Traditional | PDF ↗ |
| K230934 | ViewFlex Eco Reprocessed ICE Catheter | ABBOTT MEDICAL | 2023-05-03 | Special | PDF ↗ |
| K223026 | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Northeast Scientific, Inc. | 2023-02-03 | Traditional | PDF ↗ |
| K222217 | ViewFlex Xtra Reprocessed ICE Catheter | ABBOTT MEDICAL | 2022-12-19 | Traditional | PDF ↗ |
| K210655 | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | Innovative Health, LLC | 2022-05-25 | Traditional | PDF ↗ |
| K202042 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2020-11-20 | Special | PDF ↗ |
| K190478 | Reprocessed ViewFlex Xtra ICE Catheter | Sterilmed, Inc. | 2019-11-14 | Traditional | PDF ↗ |
| K182238 | Reprocessed ViewFlex Xtra ICE Catheter | Stryker Sustainability Solutions | 2019-05-08 | Traditional | PDF ↗ |
| K181126 | Reprocessed Visions PV .035 Digital IVUS Catheter | Innovative Health, LLC | 2019-01-18 | Traditional | PDF ↗ |
| K173262 | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2018-03-06 | Traditional | PDF ↗ |
| K163560 | Reprocessed AcuNav Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2017-07-12 | Traditional | PDF ↗ |
| K170474 | Reprocessed SoundStar 3D Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2017-06-16 | Traditional | PDF ↗ |
| K161700 | SoundStar eco 8F 3D Diagnostic eco Ultrasound Catheters, SoundStar eco 8F G 3D Diagnostic eco Ultrasound Catheters | Sterilmed, Inc. | 2016-11-21 | Traditional | PDF ↗ |
| K153090 | Reprocessed Diagnostic Ultrasound Catheter | Innovative Health, LLC | 2016-03-10 | Traditional | PDF ↗ |
| K121913 | REPROCESSED ULTRASOUND INTRACARDIAC ECHO CATHETER | Stryker Sustainability Solutions, Inc. | 2012-12-20 | Traditional | PDF ↗ |
| K110076 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETER | Sterilmed, Inc. | 2011-08-18 | Traditional | PDF ↗ |
| K092425 | REPROCESSED 3D DIAGNOSTIC ULTRASOUND CATHETERS, MODEL SNDSTR10 | Ascent Healthcare Solutions | 2009-10-21 | Traditional | PDF ↗ |
| K063076 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | Ascent Healthcare Solutions | 2007-03-29 | Traditional | PDF ↗ |
| K033436 | REPROCESSED DIAGNOSTIC ULTRASOUND CATHETER | Alliance Medical Corp. | 2005-03-16 | Traditional | PDF ↗ |
| K043453 | STERILEMED REPROCESSED IVUS IMAGING CATHETER | Sterilmed, Inc. | 2005-03-01 | Traditional | PDF ↗ |
| K012537 | REPROCESSED IMAGING CATHETERS | Sterilmed, Inc. | 2002-10-11 | Traditional | PDF ↗ |
Product code OWQ · Class II · Cardiovascular. Data: openFDA.