The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Polyethylene Catheter.
| Device ID | K181722 |
| 510k Number | K181722 |
| Device Name: | Polyethylene Catheter |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | Cook Incorporated P.O. Box 489, 750 Daniels Way Bloomington, IN 47402 |
| Contact | Reuben Lidster |
| Correspondent | Reuben Lidster Cook Incorporated P.O. Box 489, 750 Daniels Way Bloomington, IN 47402 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-06-29 |
| Decision Date | 2019-03-22 |