CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES— 510(k) K972762

Substantially Equivalent

Cardio Metrics, Inc.

FDA 510(k) clearance K972762 for CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES, Substantially Equivalent on 1997-10-14. Applicant: Cardio Metrics, Inc..

Clearance details

Applicant: Cardio Metrics, Inc.
Product code: Code DQX
Advisory panel: Cardiovascular
Date received: 1997-07-24
Decision date: 1997-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mountain View, CA, US

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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, 2020-01-01 through 2026-04-23. 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.