The following data is part of a premarket notification filed by Cook Incorporated with the FDA for 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.
| Device ID | K172527 |
| 510k 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 |
| Classification | Catheter, Nephrostomy |
| Applicant | Cook Incorporated 750 Daniels Way. P.O. Box 489 Bloomington, IN 47402 |
| Contact | Rebecca Odulio (li-chun Liu) |
| Correspondent | Rebecca Odulio (li-chun Liu) Cook Incorporated 750 Daniels Way. P.O. Box 489 Bloomington, IN 47402 |
| Product Code | LJE |
| CFR Regulation Number | 510(k) Premarket Notification [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-08-21 |
| Decision Date | 2017-10-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00827002574724 | K172527 | 000 |
| 00827002574601 | K172527 | 000 |
| 00827002574618 | K172527 | 000 |
| 00827002574625 | K172527 | 000 |
| 00827002574632 | K172527 | 000 |
| 00827002574649 | K172527 | 000 |
| 00827002574656 | K172527 | 000 |
| 00827002574663 | K172527 | 000 |
| 00827002574670 | K172527 | 000 |
| 00827002574687 | K172527 | 000 |
| 00827002574694 | K172527 | 000 |
| 00827002574700 | K172527 | 000 |
| 00827002574717 | K172527 | 000 |
| 00827002574731 | K172527 | 000 |
| 00827002574595 | K172527 | 000 |