Interventional Therapeutics Corp.: FDA filings under this applicant name
FDA lists 28 510(k) clearances under the applicant name “Interventional Therapeutics Corp.” (first 1987, latest 1996), across 13 product codes in 6 review panels. Median 510(k) review time under this name: 174 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 |
|---|---|---|---|
| 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 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.
- Interventional Spine, Inc. (8 510(k)s)
- Interventional Medical, Inc. (4 510(k)s)
- Interventional Innovations Corp. (2 510(k)s)
- Interventional Concepts, Inc. (1 510(k)s)
- Interventional Research Technologies (1 510(k)s)
- Interventional Thermodynamics, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Interventional Therapeutics Corp.?
FDA lists 28 510(k) clearances under the applicant name “Interventional Therapeutics Corp.” (first 1987, latest 1996), across 13 product codes in 6 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 Interventional Therapeutics Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Interventional Therapeutics Corp. is 174 days.
Which FDA product codes appear under Interventional Therapeutics Corp.?
The most frequent FDA product codes under this applicant name are HCG (Device, Neurovascular Embolization, 7); DQO (Catheter, Intravascular, Diagnostic, 4); FGE (Stents, Drains And Dilators For The Biliary Ducts, 4).
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. 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.