The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for U-balloon Dilation Catheter.
| Device ID | K050875 |
| 510k Number | K050875 |
| Device Name: | U-BALLOON DILATION CATHETER |
| Classification | Dilator, Catheter, Ureteral |
| Applicant | C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Contact | John C Knorpp |
| Correspondent | John C Knorpp C.R. BARD, INC. 8195 INDUSTRIAL BLVD. Covington, GA 30014 |
| Product Code | EZN |
| CFR Regulation Number | 876.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-04-06 |
| Decision Date | 2005-05-26 |
| Summary: | summary |