Cook Incorporated · Class U · Cleared Oct 19, 2017
| K-number | K172527 |
| Device name | 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 |
| Product code | LJE |
| Device class | Class U |
| Decision date | Oct 19, 2017 |
| Decision | Substantially Equivalent |
| Regulation | — |
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