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510(k) K190852

Device
Zurich Pressure Guidewire System Model 100
Applicant
Zurich Medical Inc.
510(k) number
K190852
Product code
DXO  
Decision
Substantially Equivalent (SESE)
Decision date
2019-08-14
Date received
2019-04-02
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
Yes

Applicant Contact#

Contact
Kin-Joe Sham
Address
2405 Xenium Ln. N Plymouth MN US 55441 55441

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
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
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

Legacy Summary#

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FDA Review#

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