The following data is part of a premarket notification filed by Applied Vascular Devices, Inc. with the FDA for Operative Cholangiographic Catheter.
| Device ID | K905738 |
| 510k Number | K905738 |
| Device Name: | OPERATIVE CHOLANGIOGRAPHIC CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Contact | Jo Stegwell |
| Correspondent | Jo Stegwell APPLIED VASCULAR DEVICES, INC. 26051 MERIT CIRCLE, #104 Laguna Hills, CA 92653 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-12-24 |
| Decision Date | 1991-03-21 |