The following data is part of a premarket notification filed by Medical Device Technologies, Inc. with the FDA for Fibrex Catheter Patency Device.
| Device ID | K040427 |
| 510k Number | K040427 |
| Device Name: | FIBREX CATHETER PATENCY DEVICE |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDICAL DEVICE TECHNOLOGIES, INC. 3600 SW 47TH AVENUE Gainesville, FL 32608 |
| Contact | Karl Swartz |
| Correspondent | Ned Devine ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2004-02-19 |
| Decision Date | 2004-05-03 |
| Summary: | summary |