Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cordis, A Johnson & Johnson Co. · 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) |
|---|---|---|---|---|---|
| K140286 | OPTEASE VENA CAVA FILTER AND OPTEASE RETRIEVAL CATHTETER | Cordis, A Johnson & Johnson Co. | 2014-03-07 | 30 | 0 |
| K013581 | CORDIS AVIATOR PERIPHERAL DILATATION CATHETER | Cordis, A Johnson & Johnson Co. | 2001-11-28 | 30 | 0 |
| K012090 | CORDIS PALMAZ GENESIS TRANSHEPATIC BILIARY STENT | Cordis, A Johnson & Johnson Co. | 2001-08-01 | 27 | 0 |
| K992755 | CORDIS PALMAZ CORINTHIAN TRANSHEPATIC BILIARY STENT AND DELI | Cordis, A Johnson & Johnson Co. | 1999-09-15 | 30 | 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