The following data is part of a premarket notification filed by Becton Dickinson Vascular Access, Inc. with the FDA for Insyte Artcath Arterial Catheterization Unit.
| Device ID | K921845 |
| 510k Number | K921845 |
| Device Name: | INSYTE ARTCATH ARTERIAL CATHETERIZATION UNIT |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Contact | C. J Welle |
| Correspondent | C. J Welle BECTON DICKINSON VASCULAR ACCESS, INC. 9450 SOUTH STATE ST. Sandy, UT 84070 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-04-17 |
| Decision Date | 1992-11-10 |