The following data is part of a premarket notification filed by Rusch Intl. with the FDA for Rusch Guided Cholangiography Catheter.
| Device ID | K023666 |
| 510k Number | K023666 |
| Device Name: | RUSCH GUIDED CHOLANGIOGRAPHY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Contact | Rick Lykins |
| Correspondent | Rick Lykins RUSCH INTL. 50 PLANTATION DR. Jaffery, NH 03452 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-31 |
| Decision Date | 2003-06-17 |
| Summary: | summary |