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FDA 510(k)

CARDIOMETRICS FLOWIRE & FLOMAP

K-Number: K932536 · 1993-09-28

ApplicantCardio Metrics, Inc.
Decision Date1993-09-28
Product CodeITX
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARDIOMETRICS FLOWIRE & FLOMAP 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 1993-09-28 under 510(k) number K932536. 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 CARDIOMETRICS FLOWIRE & FLOMAP?

CARDIOMETRICS FLOWIRE & FLOMAP is a medical device that received FDA 510(k) clearance on 1993-09-28. The listed applicant is Cardio Metrics, Inc.. The 510(k) number is K932536.

When did CARDIOMETRICS FLOWIRE & FLOMAP receive FDA 510(k) clearance?

CARDIOMETRICS FLOWIRE & FLOMAP received FDA 510(k) clearance on 1993-09-28, under 510(k) number K932536.

Who is the listed applicant for CARDIOMETRICS FLOWIRE & FLOMAP?

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 & FLOMAP?

The FDA product code for CARDIOMETRICS FLOWIRE & FLOMAP 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 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: 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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