K171600 is an FDA 510(k) clearance for the Renal Access Cobra Catheter, Kumpe Access Catheter. This device is classified as a Catheter, Urological (Class II - Special Controls, product code KOD).
Submitted by Cook Incorporated (Bloomington, US). The FDA issued a Cleared decision on February 16, 2018, 260 days after receiving the submission on June 1, 2017.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5130.
| 510(k) Number | K171600 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 01, 2017 |
| Decision Date | February 16, 2018 |
| Days to Decision | 260 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | KOD — Catheter, Urological |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5130 |