The following data is part of a premarket notification filed by Boston Scientific Corporation with the FDA for Uromax Ultra Balloon Dilatation Catheter.
| Device ID | K130804 |
| 510k Number | K130804 |
| Device Name: | UROMAX ULTRA BALLOON DILATATION CATHETER |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Contact | Lauren Russo |
| Correspondent | Lauren Russo Boston Scientific Corporation 100 BOSTON SCIENTIFIC WAY Marlborough, MA 01752 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2013-03-25 |
| Decision Date | 2013-05-22 |
| Summary: | summary |