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FDA 510(k)

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)

K-Number: K925524 · 1993-08-23

ApplicantCardio Metrics, Inc.
Decision Date1993-08-23
Product CodeDPW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) 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 1993-08-23 under 510(k) number K925524. The device is classified under product code DPW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)?

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) is a medical device that received FDA 510(k) clearance on 1993-08-23. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K925524.

When did CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) receive FDA 510(k) clearance?

CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) received FDA 510(k) clearance on 1993-08-23, under 510(k) number K925524.

Who is the listed applicant for CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R)?

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 SMARTWIRE(TM)/FLOMAP(R)?

The FDA product code for CARDIOMETRICS SMARTWIRE(TM)/FLOMAP(R) is DPW.

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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: DPW)

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.

K260700BlueDop Vascular ExpertBlueDop Medical, Ltd.K252810FloPatch FP120Flosonics MedicalK251904VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-CP-01, VC-SD-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Speaker Dock (VC-KIT-02, VC-TRX-02, VC-SP-01, VC-SD-01)Remington Medical, Inc.K251114FloPatch FP120Flosonics MedicalK243852Elfor-LElfi-Tech , Ltd.K241583VascuChek Kit, VascuChek Transceiver, VascuChek Clinical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-CP-01, VC-CH-01); VascuChek Kit, VascuChek Transceiver, VascuChek Surgical Probe, VascuChek Charger (VC-KIT-01, VC-TRX-01, VC-SP-01, VC-CH-01)Remington 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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