CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404— 510(k) K955551
Substantially EquivalentCardio Metrics, Inc.
FDA 510(k) clearance K955551 for CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404, Substantially Equivalent on 1996-02-28. 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
- K954913 — CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)
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.