Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiac Assist Devices, Inc. · Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K012520 | GYRO-TIP LARIAT DEFLECTABLE LOOP MAPPING CATHETER, MODEL GTL | Cardiac Assist Devices, Inc. | 2002-03-27 | 233 | 0 |
| K960849 | MAGNO ALARM | Cardiac Assist Devices, Inc. | 1997-03-26 | 400 | 0 |
| K955847 | GYRO TIP EP CATHETER | Cardiac Assist Devices, Inc. | 1997-01-29 | 400 | 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