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FDA 510(k)

CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE

K-Number: K951567 · 1996-10-25

ApplicantCardio Metrics, Inc.
Decision Date1996-10-25
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE 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 1996-10-25 under 510(k) number K951567. The device is classified under product code ITX. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE?

CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE is a medical device that received FDA 510(k) clearance on 1996-10-25. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K951567.

When did CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE receive FDA 510(k) clearance?

CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE received FDA 510(k) clearance on 1996-10-25, under 510(k) number K951567.

Who is the listed applicant for CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE?

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 CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE?

The FDA product code for CARDIOMETICS FLOWIRE, SMARTWIRE DOPPLER GUIDE WIRE is ITX.

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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 SYSTEMK961777ACCUTRAC XT INTRAVASCULAR GUIDE WIRE (FLOPPY) MODEL 2403/(FLEX) MODEL 2404K955551CARDI0METRICS FLOW WIRE XT DOPPLER GUIDE MODEL 1403, 1404K954913CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE (MODIFICATION)K952562CARDIOMETRICS ACCUTRAC INTRAVASCULAR GUIDE WIRE

View all 23 devices →

Related Devices (Code: ITX)

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.

K260114Align® Cover and Pad Guidance ToolCIVCO Medical Instruments Co., Inc.K261170BA-004CCFujifilm CorporationK254143EM-TECH Passive Ultrasound Probe StrapEM-TECH Solutions, Inc.K260161SmartGuide Disposable Guides and GridsUC-CARE , Ltd.K262474ND Needle Guidance SystemAccurate Access, LLCK261014Accuro® 3S Needle Guide KitRivanna Medical, Inc.

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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