FDA.reportPublic FDA data

510(k) K222216

Device
TruWave Disposable Pressure Transducer
Applicant
Edwards Lifesciences, LLC
510(k) number
K222216
Product code
DXO
Decision
Substantially Equivalent (SESE)
Decision date
2022-12-22
Date received
2022-07-25
Regulation
870.2870
Classification name
Transducer, Pressure, Catheter Tip
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Carmen Chen
Address
One Edwards Way Irvine CA US 92614 92614

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code DXO#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K251367OptoMonitor 3Opsens, Inc.2026-01-16
K241418OptoMonitor 3Opsens, Inc.2025-02-12
K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.2024-07-17
K202943OptoMonitor 3Opsens, Inc.2020-11-24
K193620OptoMonitor 3Opsens, Inc.2020-06-18
K193279Comet II Pressure GuidewireBoston Scientific Corporation2019-12-23
K192340OptoMonitorOpsens, Inc.2019-12-12
K190852Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.2019-08-14
K183413TruWave Disposable Pressure TransducerEdwards Lifeciences, LLC2019-05-01
K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical)2018-03-28
K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2017-10-23
K163376Mikro-Cath Pressure CatheterMillar, Inc.2017-03-10
K161263OptoMonitor IIOpsens, Inc.2016-09-13
K161171PressureWire X GuidewireSt. Jude Medical, Inc.2016-08-15
K151610Comet Pressure GuidewireBoston Scientific Corporation2015-10-06