Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cordis Leads, 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) |
|---|---|---|---|---|---|
| K883070 | ENCOR UNIPOLAR VS-1 LEADS | Cordis Leads, Inc. | 1988-12-05 | 138 | 0 |
| K873772 | CHANGES TO ENCOR PERVENOUS J-ATRIAL LEADS | Cordis Leads, Inc. | 1988-10-19 | 399 | 0 |
| K882045 | HIGH TORQUE TEMPORARY PERVENOUS LEAD W/DEPTH MARK | Cordis Leads, Inc. | 1988-07-12 | 57 | 0 |
| K874366 | ENCOR BIPOLAR ACT/FIXA LEAD W/POR SUR ELE #329-201 | Cordis Leads, Inc. | 1988-06-16 | 237 | 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