Data / Medical devices / France / Intervascular SAS
Intervascular SAS: FDA-registered device maker in LA CIOTAT Bouches-du-Rhone, France, 13 510(k) clearances
Intervascular SAS is registered with the FDA (registration 1640201) in LA CIOTAT Bouches-du-Rhone, France. It lists 4 device types. The FDA files 13 510(k) clearances under its listings, the newest dated February 2, 2011. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1640201
- FEI number
- 3002707083
- Address
- ZI Athelia 1, 270 voie Ariane, LA CIOTAT Bouches-du-Rhone, France, 13600
- Owner or operator
- Maquet Cardiovascular LLC (10024202)
- Roles
- Manufacturer
- First device listed
- January 22, 2008
- Registered through
- 2026
- Brand names listed
- Graft Sizer, HEMASHIELD, HemaCarotid Patch, HemaCarotid UltraThin Patch, HemaPatch, Hemagard Carotid Patch UltraThin, Hemagard Carotid patch, Hemagard Knitted and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Graft, Vascular, Synthetic/Biologic Composite | MAL | 2 | Manufacturer | accessdata.fda.gov |
| Instruments, Surgical, Cardiovascular | DWS | 1 | Manufacturer | accessdata.fda.gov |
| Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene | DXZ | 2 | Manufacturer | accessdata.fda.gov |
| Prosthesis, Vascular Graft, Of 6mm And Greater Diameter | DSY | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 2, 2011 | K103347 | CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | Substantially Equivalent | Intervascular Sas | accessdata.fda.gov |
| September 12, 2005 | K052302 | HEMASHIELD PLATINUM WOVEN DOUBLE VELOUR TAAA GRAFT CONFIGURATION | MAL | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| April 19, 2002 | K021213 | MODIFICATION TO HEMASHIELD PLATINUM WOVEN/MICROVEL DOUBLE VELOUR VASCULAR GRAFTS | MAL | Substantially Equivalent | Boston Scientific Corp | accessdata.fda.gov |
| February 27, 2002 | K013651 | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS | DSY | Substantially Equivalent | Intervascular | accessdata.fda.gov |
| February 22, 1999 | K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | Substantially Equivalent | Intervascular, Inc. | accessdata.fda.gov |
| November 24, 1998 | K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN | DSY | Substantially Equivalent | Intervascular, Inc. | accessdata.fda.gov |
| June 5, 1997 | K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | Substantially Equivalent - Subject to Tracking Reg. | Intervascular, Inc. | accessdata.fda.gov |
| May 5, 1997 | K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES | DSY | Substantially Equivalent - Subject to Tracking Reg. | Intervascular, Inc. | accessdata.fda.gov |
| September 10, 1996 | K962342 | HEMASHIELD FINESSE ULTRA-THIN, KNITTED CARDIOVASCULAR PATCH | DXZ | Substantially Equivalent | Meadox Medicals, Div. Boston Scientific Corp. | accessdata.fda.gov |
| February 14, 1996 | K955349 | HEMASHIELD KNITTED DOUBLE VELOUR CARDIOVASCULAR FABRIC | DXZ | Substantially Equivalent | Meadox Medicals, Div. Boston Scientific Corp. | accessdata.fda.gov |
| February 1, 1996 | K954848 | HEMASHIELD MICROVEL VELOUR KNITTED VASCULAR GRAFT | MAL | Substantially Equivalent - Subject to Tracking Reg. | Meadox Medicals, Div. Boston Scientific Corp. | accessdata.fda.gov |
| May 7, 1986 | K854431 | MEADOX MEDICALS INC. GRAFT SIZER | DSY | Substantially Equivalent | Meadox Medicals, Div. Boston Scientific Corp. | accessdata.fda.gov |
| July 20, 1976 | K760087 | TAPE, VASCULAR, 1/4 DACRON | DWS | Substantially Equivalent | Meadox Medicals, Div. Boston Scientific Corp. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| August 12, 2026 | 99745 | Class II | Ongoing | Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. HEWROOT0028, 4. HEWROOT0030, 5. HEWROOT0032, 6. HEWROOT0034 | Product failed to meet the specified acceptance criteria for Integral Water Permeability (IWP). | accessdata.fda.gov |
| December 9, 2009 | 54889 | Not yet classified | Terminated | InterGard Knitted Collagen Coated Vascular prostheses marketed under 510(k) # K964625; InterGard Woven Collagen Coated Vascular prostheses marketed under 510(k} #K970843 and K984294. | The external lid of Intervascular's prosthesis has a cut in it which may compromise package integrity and therefore sterility. | accessdata.fda.gov |
| December 9, 2009 | 54562 | Not yet classified | Terminated | InterGard Knitted Collagen Coated Vascular prostheses, Catalog number: IGK1206. InterVascular SAS, France. Indicated for surgical repair, bypass or replacement of arteries in the treatment of aneurysmal and occlusive dis | Packaging was mislabeled. | accessdata.fda.gov |
Compare with other makers
- All makers of Instruments, Surgical, Cardiovascular
- All makers of Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
- All makers of Graft, Vascular, Synthetic/Biologic Composite
- All makers of Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
Updated September 23, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.