Vti 20 MHZ Gated Doppler
FDA 510(k) K031091 · Vascular Technology Incorporated
510(k) numberK031091
Submission
- Device name
- Vti 20 MHZ Gated Doppler
- Applicant
- Vascular Technology Incorporated
Lowell, MA, US - Received
- April 7, 2003
- Decision date
- April 23, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
- Third-party review
- Yes
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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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K082870 | Vti Intraoperative Doppler SystemsDPW · Special | 10/28/2008SE |
| 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 20 MHZ Gated Doppler cleared by the FDA?
Vti 20 MHZ Gated Doppler (K031091) received a 510(k) decision of Substantially Equivalent on April 23, 2003, 16 days after the submission was received.
What is the product code of K031091?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.