The following data is part of a premarket notification filed by Intervascular, Inc. with the FDA for Modification Of Intergard Woven Collagen Coated Vascular Prostheses.
| Device ID | K984294 |
| 510k Number | K984294 |
| Device Name: | MODIFICATION OF 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 | 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 | 1998-12-01 |
| Decision Date | 1999-02-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00384401007340 | K984294 | 000 |
| 00384401000228 | K984294 | 000 |
| 00384401000235 | K984294 | 000 |
| 00384401000242 | K984294 | 000 |
| 00384401000259 | K984294 | 000 |
| 00384401000266 | K984294 | 000 |
| 00384401000273 | K984294 | 000 |
| 00384401000280 | K984294 | 000 |
| 00384401000297 | K984294 | 000 |
| 00384401000303 | K984294 | 000 |
| 00384401000310 | K984294 | 000 |
| 00384401000334 | K984294 | 000 |
| 00384401000341 | K984294 | 000 |
| 00384401005889 | K984294 | 000 |
| 00384401005896 | K984294 | 000 |
| 00384401005902 | K984294 | 000 |
| 00384401000211 | K984294 | 000 |