Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Invatec Innovative Technologies, S.R.L. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
32 daysmedian FDA review time
105 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | Invatec Innovative Technologies, S.R.L. | 2009-03-13 | 72 | 1 |
| K052791 | MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHET | Invatec Innovative Technologies, S.R.L. | 2005-11-04 | 32 | 1 |
| K051917 | DIVER C.E. CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-08-08 | 24 | 1 |
| K050756 | SKIPPER AND SKIPPER RACE GUIDEWIRE | Invatec Innovative Technologies, S.R.L. | 2005-05-05 | 43 | 0 |
| K050276 | DIVER C.E. CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-03-07 | 28 | 1 |
| K050073 | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETE | Invatec Innovative Technologies, S.R.L. | 2005-02-11 | 30 | 1 |
| K042624 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | Invatec Innovative Technologies, S.R.L. | 2005-01-10 | 105 | 1 |
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