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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifeciences, LLC. It received FDA 510(k) clearance on 2019-05-01 under 510(k) 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. The listed applicant is Edwards Lifeciences, LLC. The 510(k) number is K183413.

When did TruWave Disposable Pressure Transducer receive FDA 510(k) clearance?

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

Who is the listed applicant for TruWave Disposable Pressure Transducer?

The FDA 510(k) record lists Edwards Lifeciences, LLC as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Edwards Lifeciences, LLC 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.

K223127HemoSphere Advanced Monitoring Platform, HemoSphere ForeSight Oximeter cableK183646Acumen Hypotension Prediction Index – EV1000 Clinical Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform, Acumen Hypotension Prediction Index – HemoSphere Advanced Monitoring Platform - Pressure

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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