The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Renal Access Cobra Catheter, Kumpe Access Catheter.
| Device ID | K171600 |
| 510k Number | K171600 |
| Device Name: | Renal Access Cobra Catheter, Kumpe Access Catheter |
| Classification | Catheter, Urological |
| Applicant | Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Contact | Samuel Engelman |
| Correspondent | Samuel Engelman Cook Incorporated 750 Daniels Way Bloomington, IN 47404 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-01 |
| Decision Date | 2018-02-16 |
| Summary: | summary |