The following data is part of a premarket notification filed by Apogee Medical, Inc. with the FDA for Urological Catheter.
| Device ID | K011552 |
| 510k Number | K011552 |
| Device Name: | UROLOGICAL CATHETER |
| Classification | Catheter, Urethral |
| Applicant | APOGEE MEDICAL, INC. 90 WEATHERS ST. Youngsville, NC 27549 |
| Contact | Brent D Robling |
| Correspondent | Brent D Robling APOGEE MEDICAL, INC. 90 WEATHERS ST. Youngsville, NC 27549 |
| Product Code | GBM |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-18 |
| Decision Date | 2001-07-18 |