510(k) K181713 ยท LJE Catheter, Nephrostomy
Ultraxx Nephrostomy Balloon Catheter Set
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Aug 17, 2018 |
| Received | Jun 28, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181713
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.