FDA 510(k)

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES

K-Number: K972762 · 1997-10-14

Decision Date1997-10-14

Product CodeDQX

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES is the device name listed in this FDA 510(k) record. The listed applicant is Cardio Metrics, Inc.. It received FDA 510(k) clearance on 1997-10-14 under 510(k) number K972762. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES?

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES is a medical device that received FDA 510(k) clearance on 1997-10-14. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K972762.

When did CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES receive FDA 510(k) clearance?

CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES received FDA 510(k) clearance on 1997-10-14, under 510(k) number K972762.

Who is the listed applicant for CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES?

The FDA 510(k) record lists Cardio Metrics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES?

The FDA product code for CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRES is DQX.

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Other records listing Cardio Metrics, Inc. as applicant

K965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEM K951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE K961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404 K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404 K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)K952562CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.