The following data is part of a premarket notification filed by Vascular Technology Incorporated with the FDA for Vti Disposable Pressure Display Set.
| Device ID | K944764 |
| 510k Number | K944764 |
| Device Name: | VTI DISPOSABLE PRESSURE DISPLAY SET |
| Classification | Gauge, Pressure, Coronary, Cardiopulmonary Bypass |
| Applicant | VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
| Contact | David L Regan |
| Correspondent | David L Regan VASCULAR TECHNOLOGY INCORPORATED 25 INDUSTRIAL AVE. Chelmsford, MA 01824 |
| Product Code | DXS |
| CFR Regulation Number | 870.4310 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-27 |
| Decision Date | 1994-12-27 |