Intervascular, Inc.
Wellesley, MA, US
Intervascular, Inc. appears in FDA device records in Wellesley, MA. FDA records list 19 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 19
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 19 510(k) clearances for Intervascular, Inc. between 1984 and 2005. The busiest year on record is 1991, with 4. The most recent is 2005, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 1 |
| 1986 | 2 |
| 1988 | 2 |
| 1990 | 1 |
| 1991 | 4 |
| 1992 | 1 |
| 1997 | 2 |
| 1998 | 1 |
| 1999 | 1 |
| 2001 | 1 |
| 2002 | 2 |
| 2005 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K042984 | INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C | DWF | Substantially Equivalent | |
| K022242 | INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER | DSY | Substantially Equivalent | |
| K013651 | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K990800 | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS | DSY | Substantially Equivalent | |
| K984294 | MODIFICATION OF INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | Substantially Equivalent | |
| K983819 | INTERGARD KNITTED ULTRA THIN COLLAGEN COATED VASCULAR GRAFT AND HEMACAROTID PATCH ULTRA THIN | DSY | Substantially Equivalent | |
| K970843 | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K964625 | HEMAPATCH VASCULAR PATCHES, INTERGARD AND INTERGARD-RS VASCULAR PROSTHESES | DSY | Substantially Equivalent - Subject to Tracking Reg. | |
| K921659 | ULTRA LOW POROSITY DACRON WOVEN PATCH | DXZ | Unknown | |
| K913143 | OCHSNER ULP BIFURCATION VASCULAR PROTHESIS | DSY | Substantially Equivalent | |
| K912911 | LOW POROSITY (LP) VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K905269 | OCHSNER 500 VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K905270 | OCHSNER 50 VASCULAR PROSTHESIS | DSY | Substantially Equivalent | |
| K903964 | OCHSNER 50 BIFURCATION | DSY | Substantially Equivalent | |
| K881508 | OCHSNER & MICRON FABRIC PATCH | DXZ | Substantially Equivalent | |
| K870884 | RADIALLY-SUPPORTED VASCULAR PROSTHESES | DSY | Substantially Equivalent | |
| K862739 | INTERVASCULAR OCHSNER MICRON VASCULAR PROSTHESES | DSY | Substantially Equivalent | |
| K854845 | INTERVASCULAROCHSNER 50 AND OCHSNER 500 VASCULAR | DSY | Substantially Equivalent | |
| K833716 | LP200 & HP800 SERIES VASCULAR PROSTH | DSY | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain