Intratherapeutics, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Intratherapeutics, Inc.” (first 1998, latest 2001), across 3 product codes in 3 review panels. Median 510(k) review time under this name: 76 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 |
|---|---|---|---|
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 11 | 11 |
| DQY | Catheter, Percutaneous | 2 | 2 |
| JCT | Prosthesis, Tracheal, Expandable | 2 | 2 |
Review panels
Most recent Intratherapeutics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K011184 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | FGE | 2001-08-13 | 117 |
| K003997 | INTRASTENT DOUBLESTRUT PARAMOUNT XS BILIARY ENDOPROSTHESIS | FGE | 2001-01-24 | 29 |
| K003040 | INTRASTENT PROTEGE SELF-EXPANDING NITINOL STENT WITH STARPORT DELIVERY TECHNOLOGY | FGE | 2000-12-28 | 90 |
| K003450 | INTRASTENT DOUBLESTRUT PARAMOUNT BILIARY ENDOPROSTHESIS | FGE | 2000-12-07 | 30 |
| K001648 | INTRASTENT DOUBLESTRUT PARAMOUNT | FGE | 2000-08-28 | 90 |
| K001257 | INTRACOIL STENT | JCT | 2000-05-18 | 29 |
| K000864 | INTRASTENT DOUBLESTRUT XS STENT | FGE | 2000-04-14 | 28 |
| K993904 | INTRASTENT DOUBLESTRUT LD | FGE | 2000-02-01 | 76 |
| K992816 | MODIFICATION TO INTRASTENT | FGE | 1999-10-15 | 56 |
| K992622 | INTRAMAX ITI GUIDE CATHETER | DQY | 1999-09-29 | 55 |
5 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intratherapeutics, Inc..
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Intratherapeutics, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Intratherapeutics, Inc.” (first 1998, latest 2001), across 3 product codes in 3 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Intratherapeutics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intratherapeutics, Inc. is 76 days.
Which FDA product codes appear under Intratherapeutics, Inc.?
The most frequent FDA product codes under this applicant name are FGE (Stents, Drains And Dilators For The Biliary Ducts, 11); DQY (Catheter, Percutaneous, 2); JCT (Prosthesis, Tracheal, Expandable, 2).
Next steps
- See all 15 Intratherapeutics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FGE, Intratherapeutics, Inc.'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.