The following data is part of a premarket notification filed by W.l. Gore & Associates,inc with the FDA for Viabahn Endoprosthesis.
| Device ID | K013648 |
| 510k Number | K013648 |
| Device Name: | VIABAHN ENDOPROSTHESIS |
| Classification | Prosthesis, Tracheal, Expandable |
| Applicant | W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Contact | Timothy J Rynn |
| Correspondent | Timothy J Rynn W.L. GORE & ASSOCIATES,INC 301 AIRPORT RD Elkton, MD 21922 -1408 |
| Product Code | JCT |
| CFR Regulation Number | 878.3720 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-11-05 |
| Decision Date | 2002-01-08 |
| Summary: | summary |