INTERVASCULAR SAS
FR-MF-000002878 · France · La Ciotat
INTERVASCULAR SAS is registered in the European database on medical devices as a manufacturer, with 454 devices declared. It is also registered as a device establishment with the U.S. FDA.
What this manufacturer declares
| Class I | 454 |
|---|
Among these devices, 454 are declared sterile, 454 implantable.
Devices declared under this manufacturer
- Cardioroot Woven
- HEMASHIELD GOLD Knitted MICROVEL Double Velour Vascular Grafts
- HEMASHIELD Knitted Double Velour Cardiovascular Fabrics
- HEMASHIELD PLATINUM Woven Double Velour Vascular Grafts
- HEMASHIELD Platinum Finesse Ultra-Thin Knitted Cardiovascular Patches
- Hemacarotid Patch Knitted
- Hemagard Carotid Patch Knitted Ultrathin
- Hemagard Knitted
- Hemagard Knitted Ultrathin
- Hemagard Patch Knitted
- Hemapatch Woven
- Intergard Knitted
Showing 12 of 454 declared devices.
Catalogue references include HEK06/75CP (1), HGK0008RS15, HGKT140707R, IGKQ140706/1, IGW0034-30, M002000195170.
European nomenclature codes declared: P070102010101, P070102010102, P070102010201, P07020201, P070102010202.
United States market access
| FDA establishment register | Registered with FDA |
|---|---|
| Matched entry | Intervascular SAS (FR) · FDA 1640201 |
| Devices in EUDAMED | 454 |
| Country of registration | France |
Device-level evidence
| Devices with a numeric GTIN | 454 |
|---|---|
| Found in the U.S. device database | 403 |
| Share | 88.8 % |
Canadian market access
| Health Canada licence listing | Licensed in Canada |
|---|---|
| Matched entry | INTERVASCULAR SAS |
What it holds in Canada
| Licences on record | 10 |
|---|---|
| Currently active | 0 |
| Class 2 devices | 1 |
| Class 4 devices | 9 |
| First licensed | 1999-02-19 |
Licence types: Single Device (6), Device Family (4).
Licensed under: HEMASHIELD WOVEN DOUBLE VELOUR VASCULAR GRAFT, COLLAGEN COATED KNITTED POLYESTER VASCULAR GRA, INTERGARD WOVEN COLLAGEN COATED VASCULAR PROST, COLLAGEN COATED VASCULAR PATCHS, HEMASHIELD KNITTED DOUBLE VELOUR FABRIC, HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULA.
North American profile: Both markets. INTERVASCULAR SAS is registered in both the United States and Canada.