Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardio-Dynamics, 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) |
|---|---|---|---|---|---|
| K954313 | FOCUS PC BALLOON DILATATION CATHETER | Cardio-Dynamics, Inc. | 1995-12-01 | 77 | 0 |
| K945943 | CVD PERIFLOW(TM) BALLOON DILATATION CATHETER | Cardio-Dynamics, Inc. | 1995-02-24 | 81 | 0 |
| K942150 | CVD SMALL VESSEL BALLOON DILATION CATHETER | Cardio-Dynamics, Inc. | 1994-08-02 | 91 | 0 |
| K931027 | BULLETT PERIPHERAL INFUSION CATHETER | Cardio-Dynamics, Inc. | 1994-02-04 | 340 | 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