The following data is part of a premarket notification filed by Endovations with the FDA for Endovations Triple Lumen Balloon Dilatation Catheter.
| Device ID | K955413 |
| 510k Number | K955413 |
| Device Name: | ENDOVATIONS TRIPLE LUMEN BALLOON DILATATION CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 Reading, PA 19610 |
| Contact | Ronald D Wolfe |
| Correspondent | Ronald D Wolfe ENDOVATIONS HILL AND GEORGE AVENUES P.O. BOX 6386 Reading, PA 19610 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-11-27 |
| Decision Date | 1996-02-08 |