The following data is part of a premarket notification filed by Marian Medical, Inc. with the FDA for Guardiancatheter-urinary Drainage Catheter.
| Device ID | K063795 |
| 510k Number | K063795 |
| Device Name: | GUARDIANCATHETER-URINARY DRAINAGE CATHETER |
| Classification | Catheter, Urethral |
| Applicant | MARIAN MEDICAL, INC. 319 WESTPORT DR. Louisville, KY 40207 |
| Contact | Sandra Winkler |
| Correspondent | Sandra Winkler MARIAN MEDICAL, INC. 319 WESTPORT DR. Louisville, KY 40207 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-12-22 |
| Decision Date | 2007-03-05 |
| Summary: | summary |