Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bard Peripheral Vascular — 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) |
|---|---|---|---|---|---|
| K213896 | BD Trek Powered Bone Biopsy System | Bard Peripheral Vascular | 2022-03-30 | 106 | 0 |
| K211933 | EleVation Breast Biopsy System | Bard Peripheral Vascular | 2021-07-15 | 23 | 0 |
| K062887 | MODIFICATION TO G2 FILTER SYSTEM-FEMORAL DELIVERY KIT, MODEL | Bard Peripheral Vascular | 2006-10-26 | 30 | 0 |
| K031041 | FLUENCY TRACHEOBRONCHIAL STENT GRAFT | Bard Peripheral Vascular | 2003-06-19 | 79 | 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