The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Catheters, Biliary Catheters, Urological.
| Device ID | K944290 |
| 510k Number | K944290 |
| Device Name: | CATHETERS, BILIARY CATHETERS, UROLOGICAL |
| Classification | Tube, Drainage, Suprapubic |
| Applicant | BOSTON SCIENTIFIC CORP. 780 BROOKSIDE DR. Spencer, IN 47460 |
| Contact | Lorrain M Hanley |
| Correspondent | Lorrain M Hanley BOSTON SCIENTIFIC CORP. 780 BROOKSIDE DR. Spencer, IN 47460 |
| Product Code | FFA |
| Subsequent Product Code | FAD |
| Subsequent Product Code | FGE |
| Subsequent Product Code | LJE |
| CFR Regulation Number | 876.5090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-02 |
| Decision Date | 1994-12-08 |