Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio-Vascular Innovations, Inc. · 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) |
|---|---|---|---|---|---|
| K863917 | CVI 8.5 FRENCH PERCUTANEOUS SHEATH INTRODUCER SYS. | Cardio-Vascular Innovations, Inc. | 1987-01-06 | 90 | 0 |
| K863916 | CVI 16 GAUGE CENTRAL VEIN CATHERIZATION SYSTEM | Cardio-Vascular Innovations, Inc. | 1987-01-06 | 90 | 0 |
| K852791 | 7 FRENCH DUAL LUMEN COM CENT VEIN CATH SYS | Cardio-Vascular Innovations, Inc. | 1985-11-05 | 127 | 0 |
| K843500 | FRENCH 7 TRI-ACCESS COMPACT CENTRAL VEIN | Cardio-Vascular Innovations, Inc. | 1984-10-18 | 42 | 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