OWQ — Reprocessed Intravascular Ultrasound Catheter Class II
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 |
|---|---|---|---|
| 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 |
| K163560 | innovative health | Reprocessed AcuNav Diagnostic Ultrasound Catheter | July 12, 2017 |