FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
VTI 20 MHZ GATED DOPPLER
K Number: K031091
·
Decision Apr 23, 2003
Classifications
1
FEI Numbers
44
Registration Numbers
44
Same Product Code
136
Applicant Total
11
Review Days
16
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Basic Information
- Device Name
- VTI 20 MHZ GATED DOPPLER
- K Number
- K031091
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2100
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Vascular Technology Incorporated
- Date Received
- April 7, 2003
- Decision Date
- April 23, 2003
- Product Code
- DPW
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DPW | Flowmeter, Blood, Cardiovascular | FDA class 2 | Cardiovascular |
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Other Clearances by Vascular Technology Incorporated
| K Number | Device Name | ||
|---|---|---|---|
| K082870 | VTI INTRAOPERATIVE DOPPLER SYSTEMS | Oct 28, 2008 | Substantially Equivalent |
| K002990 | VTI ADULT DISPOSABLE SKULL PIN, MODEL 22000; VTI SKULL SCREW, MODEL 22001 | Nov 6, 2000 | Substantially Equivalent |
| K944764 | VTI DISPOSABLE PRESSURE DISPLAY SET | Dec 27, 1994 | Substantially Equivalent |
| K922738 | VTI OXYGEN ANALYZER | Jan 27, 1993 | Substantially Equivalent |
| K890058 | VASCULAR TECHNOLOGY UNIOX OXYGEN ALARM | Nov 21, 1989 | Substantially Equivalent |
| K883960 | GIPHY MONITOR | Oct 4, 1989 | Substantially Equivalent |
| K864583 | CARDIAC PERFORMANCE MONITOR | May 11, 1987 | Substantially Equivalent |
| K862114 | KHURI REGIONAL TISSUE PH MONITOR | Jun 25, 1986 | Substantially Equivalent |
| K862113 | NO. 100352 GALVANIC OXYGEN SENSOR | Jun 19, 1986 | Substantially Equivalent |
| K852275 | VASCULAR TECH # 100123 POLAROGRAPHIC OXGYEN SENSOR | Jun 20, 1985 | Substantially Equivalent |