The following data is part of a premarket notification filed by Catco Medical, Inc. with the FDA for Catco Urinary Collection Kit.
| Device ID | K945258 |
| 510k Number | K945258 |
| Device Name: | CATCO URINARY COLLECTION KIT |
| Classification | Urinary Drainage Collection Kit, For Indwelling Catheter |
| Applicant | CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
| Contact | Clyde N Baker |
| Correspondent | Clyde N Baker CATCO MEDICAL, INC. 9010 FOXLAND DR. San Antonio, TX 78230 |
| Product Code | FCN |
| CFR Regulation Number | 876.5250 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-28 |
| Decision Date | 1995-02-16 |