The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Fluency Plus Tracheobronchial Stent Graft.
| Device ID | K050832 |
| 510k Number | K050832 |
| Device Name: | FLUENCY PLUS TRACHEOBRONCHIAL STENT GRAFT |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe, AZ 85280 -1740 |
| Contact | Dennis Salzmann |
| Correspondent | Dennis Salzmann BARD PERIPHERAL VASCULAR, INC. P.O. BOX 1740 Tempe, AZ 85280 -1740 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-01 |
| Decision Date | 2005-07-07 |
| Summary: | summary |