510(k) · Cleared
ClearedVein360 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
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vein 360, LLC · OWQ Reprocessed Intravascular Ultrasound Catheter
Cleared on Oct 24, 2023 as substantially equivalent to K143701 (Volcano Corporation, 2015) and 1 other predicate after a 60-day review. Its family tree reaches back 10 generations to 1995.
- Decided
- Oct 24, 2023
- Review
- 60 days
- Class
- Class II
- Product code
- OWQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K934139 (1995). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 6 generations between
- 3 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 2 generations backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- 1 generation backK152829 Visions PV.014P RX Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- This deviceK232584 Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter…Vein 360, LLC · 2023
Show all 10 generations
- Root · 10 generations backK934139 Tomtec Echo-ViewTomtec Tomographic Technologies GmbH · 1995
- 9 generations backK993398 Echo View, Easy View, Omni ViewTomtec Imaging Systems GmbH · 1999
- 8 generations backK022824 Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV…Tomtec Imaging Systems GmbH · 2002
- 7 generations backK042188 Volcano Therapeutics, Inc. Volcano Ivus SystemVolcano Therapeutics, Inc. · 2004
- 6 generations backK051337 Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano…Volcano Corporation · 2005
- 5 generations backK073473 Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus…Volcano Corporation · 2008
- 4 generations backK092596 Eagle Eye Platinum Digital Ivus CatheterVolcano Corporation · 2009
- 3 generations backK120697 Eagle Eye Platinum ST CatheterVolcano Corporation · 2012
- 2 generations backK143701 Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter…Volcano Corporation · 2015
- 1 generation backK152829 Visions PV.014P RX Digital IVUS CatheterVolcano Corporation · 2015 · Recalled
- This deviceK232584 Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter…Vein 360, LLC · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K934139 | Tomtec Echo-View | Tomtec Tomographic Technologies GmbH | 1995 | — |
| −9 | K993398 | Echo View, Easy View, Omni View | Tomtec Imaging Systems GmbH | 1999 | — |
| −8 | K022824 | Echo-View 5.X, Easy-View 2.X, Omni View 2.X, Cardio-View 1.X, LV Analysis 1.X… | Tomtec Imaging Systems GmbH | 2002 | — |
| −7 | K042188 | Volcano Therapeutics, Inc. Volcano Ivus System | Volcano Therapeutics, Inc. | 2004 | — |
| −6 | K051337 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900/859XX; Volcano VH-Ivus… | Volcano Corporation | 2005 | — |
| −5 | K073473 | Eagle Eye Gold Ivus Imaging Catheter, Model 85900, Avabar F/X Ivus Imaging… | Volcano Corporation | 2008 | — |
| −4 | K092596 | Eagle Eye Platinum Digital Ivus Catheter | Volcano Corporation | 2009 | — |
| −3 | K120697 | Eagle Eye Platinum ST Catheter | Volcano Corporation | 2012 | — |
| −2 | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV… | Volcano Corporation | 2015 | — |
| −1 | K152829 | Visions PV.014P RX Digital IVUS Catheter | Volcano Corporation | 2015 | 1 |
| 0 (this device) | K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter, Vein360… | Vein 360, LLC | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 2 | 0 |
| 2003 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in OWQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OWQ device
- #1 K254149 Reprocessed AcuNav CRYSTAL™ Ultrasound…score 13.4 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143701 | Eagle Eye Platinum Catheter, Eagle Eye Platinum Short Tip Catheter, Visions PV .014…Summary page 6…ovascular Panel: Device OWQ Product Code: Regulatory Class II Class: Predicate Devices: The primary predicate device for this submission is K143701. The secondary predicate device for this submission is K152829. Device Description: The subject devices are reprocessed single u… | 2015 |
| * | K152829 | Visions PV.014P RX Digital IVUS CatheterSummary page 6…ulatory Class II Class: Predicate Devices: The primary predicate device for this submission is K143701. The secondary predicate device for this submission is K152829. Device Description: The subject devices are reprocessed single use devices. After clinical use of the predicate devices (Manufa… | 2015 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 28 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 13 ancestors has a recall of any class.
- 4 other devices also cite its predicate K143701.
How does its category compare?
All OWQ devicesOWQ Reprocessed Intravascular Ultrasound Catheter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · OWQ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OWQ
100in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWQ
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OWQ
42in 2025
MAUDE reports naming product code OWQ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 1 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 4 |
| 2014 | 0 | — | 1 | 2 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 2 | — | 0 | 5 |
| 2017 | 2 | — | 0 | 2 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 3 | 261 | 0 | 9 |
| 2020 | 1 | — | 0 | 29 |
| 2021 | 0 | — | 0 | 38 |
| 2022 | 2 | — | 0 | 24 |
| 2023 | 8 | 78 | 0 | 29 |
| 2024 | 1 | — | 0 | 37 |
| 2025 | 3 | 100 | 2 | 42 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014P RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX Digital IVUS catheters are all designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. These devices are not currently indicated for use in the cerebral vessels. The Vein360 Reprocessed Visions® PV .014P RX…
Read the full statement (112 words)
The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014P RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX Digital IVUS catheters are all designed for use in the evaluation of vascular morphology in blood vessels of the coronary and peripheral vasculature by providing a cross-sectional image of such vessels. These devices are not currently indicated for use in the cerebral vessels.
The Vein360 Reprocessed Visions® PV .014P RX (85910P), Visions® PV.014p RX (014R), Eagle Eye Platinum RX, and Eagle Eye Platinum ST RX Digital IVUS catheters are designed for use as an adjunct to conventional angiographic procedures to provide an image of the vessel lumen and wall structures.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K232584 · printed Nov 6, 2026
Cite this page
510(k) Report. “K232584: 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.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K232584
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026