Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cordis US Corp — 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) |
|---|---|---|---|---|---|
| K233637 | Cordis BRITECROSS Support Catheter | Cordis US Corp | 2024-06-28 | 228 | 0 |
| K232573 | INFINITI™ Ambi Angiographic Catheter | Cordis US Corp | 2023-11-21 | 88 | 0 |
| K230704 | RAIN Sheath™ Tibial Pedal Introducer | Cordis US Corp | 2023-04-24 | 41 | 0 |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatati | Cordis US Corp | 2022-08-22 | 60 | 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