The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Secura Set Volume Limiting Set.
| Device ID | K830448 |
| 510k Number | K830448 |
| Device Name: | SECURA SET VOLUME LIMITING SET |
| Classification | Set, Administration, Intravascular |
| Applicant | DIATEK, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FPA |
| CFR Regulation Number | 880.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-02-15 |
| Decision Date | 1983-02-25 |