The following data is part of a premarket notification filed by Medline Industries, Inc. with the FDA for Medline Silicone Foley Catheter.
| Device ID | K142635 |
| 510k Number | K142635 |
| Device Name: | Medline Silicone Foley Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Contact | Matt Clausen |
| Correspondent | Matt Clausen MEDLINE INDUSTRIES, INC. ONE MEDLINE PLACE Mundlelein, IL 60060 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-09-17 |
| Decision Date | 2015-01-09 |
| Summary: | summary |