510(k) K172527 ยท LJE Catheter, Nephrostomy
Amplatz Renal Dilator Set, Catheter for Use with Amplatz Renal Dilator Set, Amplatz Dilator, Amplatz Renal Introducer, Amplatz Radiopaque TFE Sheath, Clear Amplatz Sheath with Radiopaque Stripe
| Applicant | Cook Incorporated, Bloomington IN, US |
| Decision | Substantially Equivalent, Oct 19, 2017 |
| Received | Aug 21, 2017 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K172527
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.