The following data is part of a premarket notification filed by Bard Peripheral Vascular with the FDA for Fluency Tracheobronchial Stent Graft.
| Device ID | K031041 |
| 510k Number | K031041 |
| Device Name: | FLUENCY TRACHEOBRONCHIAL STENT GRAFT |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BARD PERIPHERAL VASCULAR 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Contact | Aymee R Berry |
| Correspondent | Aymee R Berry BARD PERIPHERAL VASCULAR 1625 WEST 3RD ST. Tempe, AZ 85281 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-04-01 |
| Decision Date | 2003-06-19 |
| Summary: | summary |