TruWave Disposable Pressure Transducer

FDA 510(k) K183413 · Edwards Lifeciences, LLC

Substantially Equivalent

510(k) numberK183413

Submission

Device name
TruWave Disposable Pressure Transducer
Applicant
Edwards Lifeciences, LLC
Irvine, CA, US
Received
December 10, 2018
Decision date
May 1, 2019
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
DXO – Transducer, Pressure, Catheter Tip
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2870
Specialty
Cardiovascular

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K222216TruWave Disposable Pressure TransducerDXO · Traditional Edwards Lifesciences, LLC12/22/2022SE
K202943OptoMonitor 3DXO · Traditional Opsens, Inc.11/24/2020SE
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K193279Comet II Pressure GuidewireDXO · Special Boston Scientific Corporation12/23/2019SE
K192340OptoMonitorDXO · Traditional Opsens, Inc.12/12/2019SE
K190852Zurich Pressure Guidewire System Model 100DXO · Traditional Zurich Medical, Inc.08/14/2019SE
K180558PressureWire XDXO · Special St. Jude Medical (Now Part of Abbott Medical)03/28/2018SE

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Questions and answers

When was TruWave Disposable Pressure Transducer cleared by the FDA?

TruWave Disposable Pressure Transducer (K183413) received a 510(k) decision of Substantially Equivalent on May 1, 2019, 142 days after the submission was received.

What is the product code of K183413?

The FDA product code is DXO – Transducer, Pressure, Catheter Tip, a Class II (moderate risk) device regulated under 21 CFR 870.2870.