The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Dynaflo Bypass Graft.
| Device ID | K050049 |
| 510k Number | K050049 |
| Device Name: | DYNAFLO BYPASS GRAFT |
| Classification | Prosthesis, Vascular Graft, Of 6mm And Greater Diameter |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Glenn Norton |
| Correspondent | Glenn Norton BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Product Code | DSY |
| CFR Regulation Number | 870.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-01-10 |
| Decision Date | 2005-01-31 |
| Summary: | summary |