FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
K Number: K912776
·
Decision Jan 9, 1992
Classifications
1
FEI Numbers
398
Registration Numbers
399
Same Product Code
408
Applicant Total
23
Review Days
199
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Basic Information
- Device Name
- CARDIOMETRICS FLOWIRE/FLOMAP DOPPLER ULTRASOUND
- K Number
- K912776
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 892.1570
- Medical Specialty
- Radiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Cardio Metrics, Inc.
- Date Received
- June 24, 1991
- Decision Date
- January 9, 1992
- Product Code
- ITX
- Advisory Committee
- Radiology
- Review Advisory Committee
- RA
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| ITX | Transducer, Ultrasonic, Diagnostic | FDA class 2 | Radiology |
Similar 510(k) Clearances
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Other Clearances by Cardio Metrics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K972762 | CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES | Oct 14, 1997 | Substantially Equivalent |
| K965140 | CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM | Aug 18, 1997 | Substantially Equivalent |
| K951567 | CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE | Oct 25, 1996 | Substantially Equivalent |
| K961777 | ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 | Jul 31, 1996 | Substantially Equivalent |
| K955551 | CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 | Feb 28, 1996 | Substantially Equivalent |
| K954913 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION) | Nov 7, 1995 | Substantially Equivalent |
| K952562 | CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE | Aug 29, 1995 | Substantially Equivalent |
| K943022 | CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRE | Sep 19, 1994 | Substantially Equivalent |
| K940984 | CARDIOMETRICS DUALFLOW SWITCH BOX | Aug 18, 1994 | Substantially Equivalent |
| K933320 | CARDIOMETRICS FLOMAP AND FLOMOD ULTRASOUND INSTRUMENT | Aug 17, 1994 | Substantially Equivalent |