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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 the device name listed in this FDA 510(k) record. The listed applicant is Edwards Lifesciences, LLC. It received FDA 510(k) clearance on 2017-10-23 under 510(k) 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. The listed applicant is Edwards Lifesciences, LLC. The 510(k) number is K171996.

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

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

Who is the listed applicant for TruWave Disposable Pressure Transducer?

The FDA 510(k) record lists Edwards Lifesciences, 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.

Related Clinical Trials

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.

NCT02744677COMPASSION S3 - Evaluation of the SAPIEN 3 Transcatheter Heart Valve in Patients With Pulmonary Valve DysfunctionRECRUITINGNCT03230747SAPIEN M3 EFS: Early Feasibility Study of the Edwards SAPIEN M3 System for the Treatment of Mitral RegurgitationACTIVE_NOT_RECRUITINGNCT03706833Edwards PASCAL CLASP IID/IIF Pivotal Clinical TrialACTIVE_NOT_RECRUITINGNCT03745313Edwards CLASP TR EFSCOMPLETEDNCT04097145Edwards PASCAL Transcatheter Valve Repair System Pivotal Clinical TrialRECRUITINGNCT04375332Beating Heart Mitral Valve Repair With the HARPOON™ SystemACTIVE_NOT_RECRUITING

Other records listing Edwards Lifesciences, 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.

PMA P230013Percutaneously Delivered Prostheses and Tricuspid ValvesPMA P860057replacement Heart-valvePMA P250019Prosthesis, mitral valve, percutaneously deliveredPMA P220003Mitral valve repair devicesPMA P200015Pulmonary valve prosthesis percutaneously deliveredPMA P150048heart-valve, non-allograft tissue

View all 81 devices →

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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