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
FDA 510(k) K232584 · Vein 360, LLC
510(k) numberK232584
Submission
- Device name
- 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
- Applicant
- Vein 360, LLC
Blue Ash, OH, US - Received
- August 25, 2023
- Decision date
- October 24, 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 |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterOWQ · Traditional | Vein 360, LLC | 08/25/2023SE |
| 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 |
|---|---|---|
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS CatheterOWQ · Traditional | 08/25/2023SE |
| 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.014P Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum Rx Digital IVUS Catheter, Vein360 Reprocessed Eagle Eye Platinum ST Rx Digital IVUS Catheter cleared by the FDA?
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 (K232584) received a 510(k) decision of Substantially Equivalent on October 24, 2023, 60 days after the submission was received.
What is the product code of K232584?
The FDA product code is OWQ – Reprocessed Intravascular Ultrasound Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1200.