Intervascular, Inc.: FDA filings under this applicant name
FDA lists 19 510(k) clearances under the applicant name “Intervascular, Inc.” (first 1984, latest 2005), across 3 product codes in 1 review panel. Median 510(k) review time under this name: 97 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 |
|---|---|---|---|
| DSY | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | 16 | 16 |
| DXZ | Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | 2 | 2 |
| DWF | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass | 1 | 1 |
Review panels
- Cardiovascular (19)
Most recent Intervascular, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K042984 | INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C | DWF | 2005-02-18 | 112 |
| K022242 | INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER | DSY | 2002-08-14 | 34 |
| K013651 | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS | DSY | 2002-02-27 | 113 |
| K990800 | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS | DSY | 2001-01-08 | 670 |
| K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | 1999-02-22 | 83 |
| K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN | DSY | 1998-11-24 | 26 |
| K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | 1997-06-05 | 90 |
| K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES | DSY | 1997-05-05 | 171 |
| K921659 | ULTRA LOW POROSITY DACRON WOVEN PATCH | DXZ | 1992-11-25 | 232 |
| K913143 | OCHSNER ULP BIFURCATION VASCULAR PROTHESIS | DSY | 1991-10-23 | 99 |
9 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Intervascular, 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.
Device clinical trials
An industry sponsor named Intervascular, Inc. is the lead sponsor of 1 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07322913: Intervascular Post-Market Clinical Follow-Up (PMCF) Registry (Recruiting, started 2025-12-19)
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.
- Intervascular Sas (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Intervascular, Inc.?
FDA lists 19 510(k) clearances under the applicant name “Intervascular, Inc.” (first 1984, latest 2005), 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 Intervascular, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Intervascular, Inc. is 97 days.
Which FDA product codes appear under Intervascular, Inc.?
The most frequent FDA product codes under this applicant name are DSY (Prosthesis, Vascular Graft, Of 6mm And Greater Diameter, 16); DXZ (Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, 2); DWF (Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass, 1).
Next steps
- See all 19 Intervascular, Inc. clearances with predicates and recalls
- Run predicate analysis for product code DSY, Intervascular, 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.