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FDA 510(k)

TruWave Disposable Pressure Transducer

K-Number: K171996 · 2017-10-23

ApplicantEdwards Lifesciences, LLC
Decision Date2017-10-23
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TruWave Disposable Pressure Transducer is a medical device manufactured by Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-10-23 under approval number K171996. 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 TruWave Disposable Pressure Transducer?

TruWave Disposable Pressure Transducer is a medical device that received FDA 510(k) clearance on 2017-10-23. It is manufactured by Edwards Lifesciences, LLC. The 510(k) number is K171996.

When was TruWave Disposable Pressure Transducer approved by the FDA?

TruWave Disposable Pressure Transducer received FDA 510(k) clearance on 2017-10-23, under approval number K171996.

What company makes TruWave Disposable Pressure Transducer?

TruWave Disposable Pressure Transducer is manufactured by Edwards Lifesciences, LLC.

What is the FDA product code for TruWave Disposable Pressure Transducer?

The FDA product code for TruWave Disposable Pressure Transducer is DXO.

Related Clinical Trials

NCT07273877 "Real-world Assessment of BP Control in Patients With Hypertension by the Netrod RDN System" - REACH-RDN ENROLLING_BY_INVITATION

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Related Devices (Code: DXO)

K161263OptoMonitor IIOpsens, Inc. K161171PressureWire X GuidewireSt. Jude Medical, Inc. K163376Mikro-Cath Pressure CatheterMillar, Inc. K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) K193279Comet II Pressure GuidewireBoston Scientific Corporation K192340OptoMonitorOpsens, 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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