510(k) K063632 ยท LJE Catheter, Nephrostomy
X-FORCE N30 NEPHROSTOMY BALLOON DILATION CATHETER
| Applicant | C.R. Bard, Inc., Covington GA, US |
| Decision | Substantially Equivalent, Jan 5, 2007 |
| Received | Dec 6, 2006 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K063632
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 12, 2016 | C.R. Bard, Inc. X-Force Nephrostomy Balloon Dilation Catheter Kit with Inflation Device, PTFE Sheath, 8 mm x 15 cm, Product Code 996081
The product is a dual lumen catheter with a 24 (8mm) or 30Fr (10mm) balloon mou Terminated |
LJE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.