INTERVASCULAR, SAS
FDA Regulatory Profile
INTERVASCULAR, SAS appears in FDA public data with 1 recall, 20 510(k) clearances, 2 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-3258-2026, Class II) was initiated on Aug 12, 2026. Its most recent 510(k) clearance was granted on Feb 2, 2011.
Summary
- Total Recalls
- 1
- 510(k) Clearances
- 20
- Inspections
- 2
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-3258-2026 | Class II | Cardioroot Woven Collagen Coated Vascular Graft; Model Numbers: 1. HEWROOT0024, 2. HEWROOT0026, 3. | Aug 12, 2026 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K103347 | CARDIOROOT WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Feb 2, 2011 |
| K042984 | INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C | Feb 18, 2005 |
| K022242 | INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER | Aug 14, 2002 |
| K013651 | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASC | Feb 27, 2002 |
| K990800 | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTH | Jan 8, 2001 |
| K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Feb 22, 1999 |
| K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN | Nov 24, 1998 |
| K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | Jun 5, 1997 |
| K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES | May 5, 1997 |
| K921659 | ULTRA LOW POROSITY DACRON WOVEN PATCH | Nov 25, 1992 |
| K913143 | OCHSNER ULP BIFURCATION VASCULAR PROTHESIS | Oct 23, 1991 |
| K912911 | LOW POROSITY (LP) VASCULAR PROSTHESIS | Sep 23, 1991 |
| K905269 | OCHSNER 500 VASCULAR PROSTHESIS | Apr 2, 1991 |
| K905270 | OCHSNER 50 VASCULAR PROSTHESIS | Feb 15, 1991 |
| K903964 | OCHSNER 50 BIFURCATION | Dec 3, 1990 |
| K881508 | OCHSNER & MICRON FABRIC PATCH | May 25, 1988 |
| K870884 | RADIALLY-SUPPORTED VASCULAR PROSTHESES | Feb 5, 1988 |
| K862739 | INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES | Aug 21, 1986 |
| K854845 | INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR | Aug 18, 1986 |
| K833716 | LP200 & HP800 SERIES VASCULAR PROSTH | Jan 10, 1984 |