K172527 is an FDA 510(k) clearance for the 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. This device is classified as a Catheter, Nephrostomy.
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on October 19, 2017, 59 days after receiving the submission on August 21, 2017.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K172527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 21, 2017 |
| Decision Date | October 19, 2017 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |