Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cardiovention, 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) |
|---|---|---|---|---|---|
| K032068 | CARDIOVENTION CORX IOS-200 SYSTEM, MODEL IOS-200 | Cardiovention, Inc. | 2003-08-22 | 50 | 0 |
| K030141 | MODIFICATION TO CARDIOVENTION POWERBASE CONSOLE, MODEL PCB-1 | Cardiovention, Inc. | 2003-02-26 | 42 | 0 |
| K021694 | CARDIOVENTION POWERBASE CONSOLE, MODEL PBC-100 | Cardiovention, Inc. | 2003-01-08 | 231 | 0 |
| K012325 | CARDIOVENTION CORX SYSTEM, MODEL FG 0001 | Cardiovention, Inc. | 2002-04-09 | 260 | 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