The following data is part of a premarket notification filed by Diatek, Inc. with the FDA for Secura Set.
| Device ID | K841859 | 
| 510k Number | K841859 | 
| Device Name: | SECURA 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 | 1984-05-04 | 
| Decision Date | 1984-07-03 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  SECURA SET  73433686  1350491 Dead/Cancelled | DIATEK, INC. 1983-07-08 |