The following data is part of a premarket notification filed by Catheter Technology Corp. with the FDA for Cath-tech Cholangiography Catheter.
| Device ID | K842147 |
| 510k Number | K842147 |
| Device Name: | CATH-TECH CHOLANGIOGRAPHY CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | CATHETER TECHNOLOGY CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-30 |
| Decision Date | 1984-10-02 |