The following data is part of a premarket notification filed by Deseret Medical, Inc. with the FDA for Vessel Dilator.
| Device ID | K913027 |
| 510k Number | K913027 |
| Device Name: | VESSEL DILATOR |
| Classification | Dilator, Vessel, For Percutaneous Catheterization |
| Applicant | DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | Becton Dickinson |
| Correspondent | Becton Dickinson DESERET MEDICAL, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | DRE |
| CFR Regulation Number | 870.1310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-09 |
| Decision Date | 1991-11-27 |