The following data is part of a premarket notification filed by Vitalcare, Inc. with the FDA for Vitalcare Foley Catheter.
| Device ID | K021939 |
| 510k Number | K021939 |
| Device Name: | VITALCARE FOLEY CATHETER |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | VITALCARE, INC. 15800 NW 13TH AVE. Miami, FL 33169 |
| Contact | Michael Mcavenia |
| Correspondent | Michael Mcavenia VITALCARE, INC. 15800 NW 13TH AVE. Miami, FL 33169 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-12 |
| Decision Date | 2003-04-22 |
| Summary: | summary |