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FDA 510(k)

TruWave Disposable Pressure Transducer

K-Number: K183413 · 2019-05-01

ApplicantEdwards Lifeciences, LLC
Decision Date2019-05-01
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TruWave Disposable Pressure Transducer is a medical device manufactured by Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2019-05-01 under approval number K183413. 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 2019-05-01. It is manufactured by Edwards Lifeciences, LLC. The 510(k) number is K183413.

When was TruWave Disposable Pressure Transducer approved by the FDA?

TruWave Disposable Pressure Transducer received FDA 510(k) clearance on 2019-05-01, under approval number K183413.

What company makes TruWave Disposable Pressure Transducer?

TruWave Disposable Pressure Transducer is manufactured by Edwards Lifeciences, 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

Other Devices by Edwards Lifeciences, LLC

K183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cable

Related Devices (Code: DXO)

K161263OptoMonitor IIOpsens, Inc. K161171PressureWire X GuidewireSt. Jude Medical, Inc. K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K163376Mikro-Cath Pressure CatheterMillar, Inc. K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) K193279Comet II Pressure GuidewireBoston Scientific Corporation

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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