CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES— 510(k) K941485
Substantially EquivalentCardio Metrics, Inc.
FDA 510(k) clearance K941485 for CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES, Substantially Equivalent on 1994-05-31. Applicant: Cardio Metrics, Inc.. Device class: 2.
Clearance details
- Applicant
- Cardio Metrics, Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code DQX
view allMore clearances from Cardio Metrics, Inc.
view all- K972762 — CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES
- K965140 — CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM
- K951567 — CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE
- K961777 — ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404
- K955551 — CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.