The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for X-force N30 Nephrostomy Balloon Dilation Catheter.
| Device ID | K063632 |
| 510k Number | K063632 |
| Device Name: | X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER |
| Classification | Catheter, Nephrostomy |
| Applicant | C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Contact | Terri Morris |
| Correspondent | Terri Morris C.R. BARD, INC. 13183 HARLAND DRIVE Covington, GA 30014 -6421 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-06 |
| Decision Date | 2007-01-05 |
| Summary: | summary |