OWQ
- Product code
- OWQ
- Device name
- Reprocessed Intravascular Ultrasound Catheter
- Device class
- Class 2
- 21 CFR
- 21 CFR 870.1200
- Medical specialty
- Cardiovascular
- Marketing pathway
- 510(K)
- 510(k) clearances (last 3 years)
- 7
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 31 (all years; only the last 3 years are listed here)
FDA classification definition
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
510(k) clearances, last 3 years (7)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K254149 | 2026-06-29 | Sterilmed, Inc. | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x… | |
| K250545 | 2025-06-05 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Biosense Webster SOUNDST… | |
| K250592 | 2025-05-12 | Northeast Scientific, Inc. | NES Reprocessed Visions PV .018 Digital IVUS Cathete… | |
| K243101 | 2025-03-10 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10… | |
| K234064 | 2024-09-10 | Surgical Instrument Service and Saving… | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F… | |
| K232130 | 2023-12-15 | Surgical Instrument Services and Savin… | Medline ReNewal Reprocessed ViewFlex Xtra ICE Cathet… | |
| K232584 | 2023-10-24 | Vein 360, LLC | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS … |
Official FDA classification page: OWQ
Classification and pathway per current FDA publications. Data from openFDA (CC0).