Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Creganna-Tactx Medical · Predicate Candidate Screening
2 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K140338 | CREGANNA TACTX LOTUS INTRODUCER SET (SMALL), CREGANNA TACTX | Creganna-Tactx Medical | 2014-08-27 | 198 | 0 |
| K110133 | EMPIRA RX PTCA DILATATION CATHETER, EMPRIA NC RX PTCA DILATA | Creganna-Tactx Medical | 2011-06-10 | 143 | 3 |
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