The following data is part of a premarket notification filed by Intervascular with the FDA for Intergard Hemabridge Collagen Coated Vascular Prosthesis, Intergard Aortic Arch Collagen Coated Vascular Prosthesis.
| Device ID | K013651 |
| 510k Number | K013651 |
| Device Name: | INTERGARD HEMABRIDGE COLLAGEN COATED VASCULAR PROSTHESIS, INTERGARD AORTIC ARCH COLLAGEN COATED VASCULAR PROSTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | INTERVASCULAR 20 WALNUT ST.; SUITE 12 Wellesley, MA 02481 |
| Contact | Amy Aulwes |
| Correspondent | Amy Aulwes INTERVASCULAR 20 WALNUT ST.; SUITE 12 Wellesley, MA 02481 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-06 |
| Decision Date | 2002-02-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401103868 | K013651 | 000 |
| 00384401001027 | K013651 | 000 |
| 00384401001034 | K013651 | 000 |
| 00384401001232 | K013651 | 000 |
| 00384401001249 | K013651 | 000 |
| 00384401001386 | K013651 | 000 |
| 00384401006190 | K013651 | 000 |
| 00384401006930 | K013651 | 000 |
| 00384401007265 | K013651 | 000 |
| 00384401010722 | K013651 | 000 |
| 00384401010739 | K013651 | 000 |
| 00384401010746 | K013651 | 000 |
| 00384401010753 | K013651 | 000 |
| 00384401010760 | K013651 | 000 |
| 00384401103844 | K013651 | 000 |
| 00384401103851 | K013651 | 000 |
| 00384401001010 | K013651 | 000 |