Vti Intraoperative Doppler Systems
FDA 510(k) K082870 · Vascular Technology Incorporated
510(k) numberK082870
Submission
- Device name
- Vti Intraoperative Doppler Systems
- Applicant
- Vascular Technology Incorporated
Nashua, NH, US - Received
- September 29, 2008
- Decision date
- October 28, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K944764 | Vti Disposable Pressure Display SetDXS · Traditional | 12/27/1994SE |
| 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 Intraoperative Doppler Systems cleared by the FDA?
Vti Intraoperative Doppler Systems (K082870) received a 510(k) decision of Substantially Equivalent on October 28, 2008, 29 days after the submission was received.
What is the product code of K082870?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.