The following data is part of a premarket notification filed by Compactcath Inc with the FDA for Compactcath Intermittent Urinary Catheter.
| Device ID | K140945 |
| 510k Number | K140945 |
| Device Name: | COMPACTCATH INTERMITTENT URINARY CATHETER |
| Classification | Catheter, Straight |
| Applicant | COMPACTCATH INC 3924 CASCADE BEACH ROAD Lutsen, MN 55612 |
| Contact | Gregory Mathison |
| Correspondent | Gregory Mathison COMPACTCATH INC 3924 CASCADE BEACH ROAD Lutsen, MN 55612 |
| Product Code | EZD |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-04-14 |
| Decision Date | 2014-08-22 |
| Summary: | summary |