The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Intergard Knitted Ultra Thin And Intergard Knitted Collagen Coated And Heparin Bonded Vascular Prothesis.
| Device ID | K990800 |
| 510k Number | K990800 |
| Device Name: | INTERGARD KNITTED ULTRA THIN AND INTERGARD KNITTED COLLAGEN COATED AND HEPARIN BONDED VASCULAR PROTHESIS |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Contact | James S Miller |
| Correspondent | James S Miller INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-10 |
| Decision Date | 2001-01-08 |
| Summary: | summary |