Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
FDA 510(k) K230928 · Vein 360, LLC
510(k) numberK230928
Submission
- Device name
- Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter
- Applicant
- Vein 360, LLC
Blue Ash, OH, US - Received
- April 3, 2023
- Decision date
- August 25, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OWQ – Reprocessed Intravascular Ultrasound Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
Other 510(k)s with product code OWQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254149 | Reprocessed AcuNav CRYSTAL Ultrasound Catheter 9F x 90 CM, For Use on Siemens System…OWQ · Traditional | Sterilmed, Inc. | 06/29/2026SE |
| K250545 | Medline ReNewal Reprocessed Biosense Webster SOUNDSTAR eco Diagnostic Ultrasound…OWQ · Traditional | Surgical Instrument Service and Savings, Inc. | 06/05/2025SE |
| K250592 | NES Reprocessed Visions PV .018 Digital IVUS Catheter (R-86700)OWQ · Traditional | Northeast Scientific, Inc. | 05/12/2025SE |
| K243101 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 10F Ultrasound Catheter (for Siemens…OWQ · Traditional | Surgical Instrument Service and Savings, Inc. | 03/10/2025SE |
| K234064 | Medline ReNewal Reprocessed Siemens ACUSON AcuNav 8F Ultrasound Catheter (for Siemens…OWQ · Traditional | Surgical Instrument Service and Savings, Inc. | 09/10/2024SE |
| K232130 | Medline ReNewal Reprocessed ViewFlex Xtra ICE CatheterOWQ · Traditional | Surgical Instrument Services and Savings, Inc. | 12/15/2023SE |
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…OWQ · Traditional | Vein 360, LLC | 10/24/2023SE |
| K231621 | Reprocessed ViewFlex Xtra ICE Catheter (D087031)OWQ · Special | Stryker Sustainability Solutions | 07/25/2023SE |
| K231588 | ViewFlex Eco Reprocessed ICE CatheterOWQ · Special | Abbott Medical | 06/30/2023SE |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterOWQ · Traditional | Vein 360, LLC | 06/06/2023SE |
More from Vein 360, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle…OWQ · Traditional | 10/24/2023SE |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS CatheterOWQ · Traditional | 06/06/2023SE |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) CatheterNUJ · Traditional | 10/22/2019SE |
Questions and answers
When was Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter cleared by the FDA?
Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter (K230928) received a 510(k) decision of Substantially Equivalent on August 25, 2023, 144 days after the submission was received.
What is the product code of K230928?
The FDA product code is OWQ – Reprocessed Intravascular Ultrasound Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1200.