The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Intergard Woven Collagen Coated Vascular Prostheses.
| Device ID | K970843 |
| 510k Number | K970843 |
| Device Name: | INTERGARD WOVEN COLLAGEN COATED VASCULAR PROSTHESES |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Contact | Melissa L Billman |
| Correspondent | Melissa L Billman INTERVASCULAR, INC. 16331 BAY VISTA DR. Clearwater, FL 33760 -3130 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Se Subject To Tracking Reg (ST) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-07 |
| Decision Date | 1997-06-05 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401006459 | K970843 | 000 |
| 00384401000150 | K970843 | 000 |
| 00384401000143 | K970843 | 000 |
| 00384401000136 | K970843 | 000 |
| 00384401000129 | K970843 | 000 |
| 00384401000112 | K970843 | 000 |
| 00384401000105 | K970843 | 000 |
| 00384401000099 | K970843 | 000 |
| 00384401000082 | K970843 | 000 |
| 00384401000075 | K970843 | 000 |
| 00384401000051 | K970843 | 000 |
| 00384401000037 | K970843 | 000 |
| 00384401000167 | K970843 | 000 |
| 00384401000174 | K970843 | 000 |
| 00384401005872 | K970843 | 000 |
| 00384401000594 | K970843 | 000 |
| 00384401000587 | K970843 | 000 |
| 00384401000570 | K970843 | 000 |
| 00384401000563 | K970843 | 000 |
| 00384401000556 | K970843 | 000 |
| 00384401000549 | K970843 | 000 |
| 00384401000532 | K970843 | 000 |
| 00384401000204 | K970843 | 000 |
| 00384401000198 | K970843 | 000 |
| 00384401000181 | K970843 | 000 |
| 00384401000013 | K970843 | 000 |