Interventional Therapeutics Corp.: FDA clearances and approvals
Interventional Therapeutics Corp. has 28 FDA 510(k) clearances (first 1987, latest 1996), across 13 product codes in 6 review panels. Median 510(k) review time: 174 days.
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 |
|---|---|---|---|
| HCG | Device, Neurovascular Embolization | 7 | 7 |
| DQO | Catheter, Intravascular, Diagnostic | 4 | 4 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 4 | 4 |
| DQY | Catheter, Percutaneous | 3 | 3 |
| DYB | Introducer, Catheter | 2 | 2 |
| DQA | Oximeter | 1 | 1 |
| DTL | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | 1 | 1 |
| DXC | Clamp, Vascular | 1 | 1 |
| DYG | Catheter, Flow Directed | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
Plus 3 more product codes.
Review panels
- Cardiovascular (13)
- Neurology (7)
- Gastroenterology and Urology (5)
- Anesthesiology (1)
- General Hospital (1)
- General and Plastic Surgery (1)
Most recent Interventional Therapeutics Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K960832 | OCCLUSION BALLOON CATHETER | MJN | 1996-05-29 | 90 |
| K950398 | CATHETER, BALLOON TYPE | DQO | 1995-10-05 | 246 |
| K945588 | DISPOSABLE 1CC SYRINGE WITH LUER LOCK | FMF | 1995-02-10 | 88 |
| K944354 | CONTOUR EMBOLI | HCG | 1994-12-13 | 105 |
| K930456 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | KNT | 1993-11-17 | 294 |
| K914866 | ITC CONTOUR EMBOLI, MODIFICATION | HCG | 1993-11-09 | 742 |
| K931025 | INTHERM STASIS VALVE SYSTEM | FGE | 1993-09-28 | 211 |
| K931278 | INTHERM SINGLE-STICK RADIALLY EXPANDING DILATOR | GCJ | 1993-07-23 | 137 |
| K922609 | ITC CATHETERS W/ HYDROMER | DQY | 1993-04-30 | 332 |
| K925876 | ITC BUNJI PLATINUM EMBOLIZATION COIL | HCG | 1993-04-15 | 147 |
18 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Interventional Therapeutics Corp..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Interventional Therapeutics Corp. have?
Interventional Therapeutics Corp. has 28 FDA 510(k) clearances (first 1987, latest 1996), across 13 product codes in 6 review panels.
How long does FDA take to clear Interventional Therapeutics Corp.'s 510(k)s?
The median time from FDA receipt to decision across Interventional Therapeutics Corp.'s cleared 510(k)s is 174 days.
What devices does Interventional Therapeutics Corp. make?
Its most frequent FDA product codes are HCG (Device, Neurovascular Embolization, 7); DQO (Catheter, Intravascular, Diagnostic, 4); FGE (Stents, Drains And Dilators For The Biliary Ducts, 4).
Has Interventional Therapeutics Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Interventional Therapeutics Corp. Related entities may recall under other names.
Next steps
- See all 28 Interventional Therapeutics Corp. clearances with predicates and recalls
- Run predicate analysis for product code HCG, Interventional Therapeutics Corp.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.