The following data is part of a premarket notification filed by Intervascular with the FDA for Intervascular Intergard Knitted Vascular Graft Sizer.
| Device ID | K022242 |
| 510k Number | K022242 |
| Device Name: | INTERVASCULAR INTERGARD KNITTED VASCULAR GRAFT SIZER |
| 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 | 2002-07-11 |
| Decision Date | 2002-08-14 |
| Summary: | summary |