The following data is part of a premarket notification filed by Wiltek Medical, Inc. with the FDA for Wiltek Balloon Cholangiography Catheter.
| Device ID | K914882 |
| 510k Number | K914882 |
| Device Name: | WILTEK BALLOON CHOLANGIOGRAPHY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem, NC 27116 |
| Contact | Jon S Wilson |
| Correspondent | Jon S Wilson WILTEK MEDICAL, INC. P.O.BOX 11946 Winston-salem, NC 27116 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-30 |
| Decision Date | 1992-01-07 |