K172929 is an FDA 510(k) clearance for the Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath. This device is classified as a Catheter, Nephrostomy.
Submitted by Boston Scientific Corporation (Marlboro, US). The FDA issued a Cleared decision on January 10, 2018, 107 days after receiving the submission on September 25, 2017.
This device falls under the Gastroenterology & Urology FDA review panel.
| 510(k) Number | K172929 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 2017 |
| Decision Date | January 10, 2018 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | LJE — Catheter, Nephrostomy |
| Device Class | — |