Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Vein 360, LLC · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K232584 | Vein360 Reprocessed Visions PV.014P Rx Digital IVUS Catheter | Vein 360, LLC | 2023-10-24 | 60 | 0 |
| K230928 | Vein360 Reprocessed Visions PV.018 Digital IVUS Catheter | Vein 360, LLC | 2023-08-25 | 144 | 0 |
| K230584 | Vein360 Reprocessed Visions PV.035 Digital IVUS Catheter | Vein 360, LLC | 2023-06-06 | 96 | 0 |
| K191073 | Vein360 Endovenous Radiofrequency Ablation (RFA) Catheter | Vein 360, LLC | 2019-10-22 | 183 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda