OWQ — Reprocessed Intravascular Ultrasound Catheter Class II
FDA product code OWQ covers "Reprocessed Intravascular Ultrasound Catheter", a Class II medical device regulated under 21 CFR 870.1200. Submissions are reviewed by the Cardiovascular panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OWQ
- Device Class
- Class II
- Regulation Number
- 870.1200
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
Definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K254149 | sterilmed | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens S | June 29, 2026 |
| K250545 | surgical instrument service and savings | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound | June 5, 2025 |
| K250592 | northeast scientific | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700) | May 12, 2025 |
| K243101 | surgical instrument service and savings | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for S | March 10, 2025 |
| K234064 | surgical instrument service and savings | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Si | September 10, 2024 |
| K232130 | surgical instrument services and savings | Medline ReNewal Reprocessed ViewFlex Xtra ICE Catheter | December 15, 2023 |
| K232584 | vein 360 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocesse | October 24, 2023 |
| K230928 | vein 360 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | August 25, 2023 |
| K231621 | stryker sustainability solutions | Reprocessed ViewFlex Xtra ICE Catheter (D087031) | July 25, 2023 |
| K231588 | abbott medical | ViewFlex Eco Reprocessed ICE Catheter | June 30, 2023 |
| K230584 | vein 360 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | June 6, 2023 |
| K230934 | abbott medical | ViewFlex Eco Reprocessed ICE Catheter | May 3, 2023 |
| K223026 | northeast scientific | NES Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | February 3, 2023 |
| K222217 | abbott medical | ViewFlex Xtra Reprocessed ICE Catheter | December 19, 2022 |
| K210655 | innovative health | Reprocessed Eagle Eye Platinum RX Digital IVUS Catheter | May 25, 2022 |
| K202042 | innovative health | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | November 20, 2020 |
| K190478 | sterilmed | Reprocessed ViewFlex Xtra ICE Catheter | November 14, 2019 |
| K182238 | stryker sustainability solutions | Reprocessed ViewFlex Xtra ICE Catheter | May 8, 2019 |
| K181126 | innovative health | Reprocessed Visions PV .035 Digital IVUS Catheter | January 18, 2019 |
| K173262 | innovative health | Reprocessed ViewFlex Xtra Ice Diagnostic Ultrasound Catheter | March 6, 2018 |