FDA.report

510(k) K251367

Device
OptoMonitor 3
Applicant
Opsens, Inc.
510(k) number
K251367
Product code
DXO
Decision
Substantially Equivalent (SESE)
Decision date
2026-01-16
Date received
2025-05-01
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
N

Related Records

Applicant Contact

Contact
Dany Simard
Address
750 Blvd. Du Parc Technologique Quebec CA G1P 4S3 G1P 4S3

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code DXO

510(k)DeviceApplicantDecision date
K241418OptoMonitor 3Opsens, Inc.2025-02-12
K233904ACIST RXi System (016616); ACIST Navvus II Catheter (016675_Acist Medical Systems, Inc.2024-07-17
K222216TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC2022-12-22
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