Vti Disposable Pressure Display Set
FDA 510(k) K944764 · Vascular Technology Incorporated
510(k) numberK944764
Submission
- Device name
- Vti Disposable Pressure Display Set
- Applicant
- Vascular Technology Incorporated
Chelmsford, MA, US - Received
- September 27, 1994
- Decision date
- December 27, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4310
- Specialty
- Cardiovascular
Other 510(k)s with product code DXS
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113235 | Pressure Display Box,Dlp Disposable Pressure Display Sets-Non Sterile VersionsDXS · Special | Medtronic, Inc. | 12/02/2011SE |
| K912045 | TMP Pressure Isolatorr, TMP Pressure Monitor SystDXS · Traditional | Lifestream Int'L, Inc. | 10/31/1991SE |
| K900797 | Stockert Shiley Dual Pressure Control Module XRDXS · Traditional | Shiley, Inc. | 05/10/1990SE |
| K873802 | Pressure Barrier Kit Cat. No. PBK-3DXS · Traditional | American Omni Medical, Inc. | 11/06/1987SE |
| K862836 | Stockert-Shiley Caps and Caps Dual Pressure ModuleDXS · Traditional | Shiley, Inc. | 09/12/1986SE |
| K852232 | Pressure Display Box #60000/TUBING Set #61000DXS · Traditional | Dlp, Inc. | 08/09/1985SE |
| K842194 | Pressure MonitorDXS · Traditional | Norton Texas Medical Products | 08/27/1984SE |
| K831750 | PM-3DXS · Traditional | Delta Medical Industries | 07/26/1983SE |
| K822822 | Gambro Pressure Monitor PRM 10DXS · Traditional | Gambro, Inc. | 10/18/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | Delta Medical Industries | 05/18/1982SE |
More from Delta Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K082870 | Vti Intraoperative Doppler SystemsDPW · Special | 10/28/2008SE |
| K031091 | Vti 20 MHZ Gated DopplerDPW · Traditional | 04/23/2003SE |
| K002990 | Vti Adult Disposable Skull Pin, Model 22000; Vti Skull Screw, Model 22001HBL · Traditional | 11/06/2000SE |
| K922738 | Vti Oxygen AnalyzerCCL · Traditional | 01/27/1993SE |
| K890058 | Vascular Technology Uniox Oxygen AlarmCCL · Traditional | 11/21/1989SE |
| K883960 | Giphy MonitorFFT · Traditional | 10/04/1989SE |
| K864583 | Cardiac Performance MonitorDQK · Traditional | 05/11/1987SE |
| K862114 | Khuri Regional Tissue PH MonitorCBZ · Traditional | 06/25/1986SE |
| K862113 | No. 100352 Galvanic Oxygen SensorCCL · Traditional | 06/19/1986SE |
| K852275 | Vascular Tech # 100123 Polarographic Oxgyen SensorCCL · Traditional | 06/20/1985SE |
Questions and answers
When was Vti Disposable Pressure Display Set cleared by the FDA?
Vti Disposable Pressure Display Set (K944764) received a 510(k) decision of Substantially Equivalent on December 27, 1994, 91 days after the submission was received.
What is the product code of K944764?
The FDA product code is DXS – Gauge, Pressure, Coronary, Cardiopulmonary Bypass, a Class II (moderate risk) device regulated under 21 CFR 870.4310.