Invatec Innovative Technologies, S.R.L.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Invatec Innovative Technologies, S.R.L.” (first 2005, latest 2009), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 32 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
Caduvo groups this applicant name under Medtronic, based on public ownership records.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| DQY | Catheter, Percutaneous | 4 | 4 |
| QEZ | Aspiration Thrombectomy Catheter | 2 | 2 |
| DQX | Wire, Guide, Catheter | 1 | 1 |
Review panels
- Cardiovascular (7)
Most recent Invatec Innovative Technologies, S.R.L. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K083919 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | 2009-03-13 | 72 |
| K052791 | MODIFICATION TO: AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | 2005-11-04 | 32 |
| K051917 | DIVER C.E. CATHETER | QEZ | 2005-08-08 | 24 |
| K050756 | SKIPPER AND SKIPPER RACE GUIDEWIRE | DQX | 2005-05-05 | 43 |
| K050276 | DIVER C.E. CATHETER | QEZ | 2005-03-07 | 28 |
| K050073 | MODIFICATION TO AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | 2005-02-11 | 30 |
| K042624 | AMPHIRION DEEP 0.014 OTW PTA BALLOON CATHETER | DQY | 2005-01-10 | 105 |
Recalls
openFDA lists no recalls under a recalling firm named Invatec Innovative Technologies, S.R.L..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Invatec S.P.A. (4 510(k)s)
- Invatec Innovative Technologies (3 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Invatec Innovative Technologies, S.R.L.?
FDA lists 7 510(k) clearances under the applicant name “Invatec Innovative Technologies, S.R.L.” (first 2005, latest 2009), across 3 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Invatec Innovative Technologies, S.R.L.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Invatec Innovative Technologies, S.R.L. is 32 days.
Which FDA product codes appear under Invatec Innovative Technologies, S.R.L.?
The most frequent FDA product codes under this applicant name are DQY (Catheter, Percutaneous, 4); QEZ (Aspiration Thrombectomy Catheter, 2); DQX (Wire, Guide, Catheter, 1).
Next steps
- See all 7 Invatec Innovative Technologies, S.R.L. clearances with predicates and recalls
- Run predicate analysis for product code DQY, Invatec Innovative Technologies, S.R.L.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.