Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cagent Vascular, LLC — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
55 daysmedian FDA review time
149 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K220704 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2022-05-04 | 55 | 0 |
| K213728 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2021-12-15 | 19 | 0 |
| K203437 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-12-22 | 29 | 0 |
| K193181 | Serranator PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2020-04-15 | 149 | 0 |
| K163380 | Serranator Alto PTA Serration Balloon Catheter | Cagent Vascular, LLC | 2017-02-13 | 74 | 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