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FDA 510(k)

CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES

K-Number: K941485 · 1994-05-31

ApplicantCardio Metrics, Inc.
Decision Date1994-05-31
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMETRICS FLOWIRE 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 1994-05-31 under 510(k) number K941485. 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 DOPPLER GUIDE WIRES?

CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES is a medical device that received FDA 510(k) clearance on 1994-05-31. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K941485.

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

CARDIOMETRICS FLOWIRE DOPPLER GUIDE WIRES received FDA 510(k) clearance on 1994-05-31, under 510(k) number K941485.

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

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

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Other records listing Cardio Metrics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K972762CARDIOMETRICS FLOWIRE 300 AND XT 300 DOPPLER GUIDE WIRESK965140CARDIOMETRICS WAVEWIRE/WAVEMAP PRESSURE SYSTEMK951567CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIREK961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)

View all 23 devices →

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253146Hyperdrive 35 GuidewireRapid-Medical , Ltd.K261281CROSSLEAD Standard 035 and CROSSLEAD Stiff 035Filmecc Co., Ltd.K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.

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.

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