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FDA 510(k)

SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX

K-Number: K070487 · 2007-03-16

ApplicantVolcano Corporation
Decision Date2007-03-16
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX is the device name listed in this FDA 510(k) record. The listed applicant is Volcano Corporation. It received FDA 510(k) clearance on 2007-03-16 under 510(k) number K070487. The device is classified under product code DXO. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX?

SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX is a medical device that received FDA 510(k) clearance on 2007-03-16. The listed applicant is Volcano Corporation. The 510(k) number is K070487.

When did SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX receive FDA 510(k) clearance?

SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX received FDA 510(k) clearance on 2007-03-16, under 510(k) number K070487.

Who is the listed applicant for SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX?

The FDA 510(k) record lists Volcano Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX?

The FDA product code for SMARTWIRE PRESSURE GUIDE WIRE, MODEL 66XX is DXO.

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Related Devices (Code: DXO)

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.

K251367OptoMonitor 3Opsens, Inc.K241418OptoMonitor 3Opsens, Inc.K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLCK202943OptoMonitor 3Opsens, Inc.K193620OptoMonitor 3Opsens, 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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