The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Poly-cath Red Polymer Urethral Catheter.
| Device ID | K183335 |
| 510k Number | K183335 |
| Device Name: | Medline Poly-Cath Red Polymer Urethral Catheter |
| Classification | Catheter, Urological |
| Applicant | Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Contact | Dinah Rincones |
| Correspondent | Dinah Rincones Medline Industries, Inc. Three Lakes Drive Northfield, IL 60093 |
| Product Code | KOD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-12-03 |
| Decision Date | 2019-06-12 |