K080944 is an FDA 510(k) clearance for the X-FORCE NEPHROSTOMY BALLOON DILATION CATHETER. This device is classified as a Catheter, Nephrostomy.
Submitted by C.R. Bard, Inc. (Covington, US). The FDA issued a Cleared decision on October 23, 2008, 203 days after receiving the submission on April 3, 2008.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K080944 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 2008 |
| Decision Date | October 23, 2008 |
| Days to Decision | 203 days |
| Submission Type | Special |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |