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FDA 510(k)

Zurich Pressure Guidewire System Model 100

K-Number: K190852 · 2019-08-14

ApplicantZurich Medical, Inc.
Decision Date2019-08-14
Product CodeDXO
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Zurich Pressure Guidewire System Model 100 is a medical device manufactured by Zurich Medical, Inc.. It received FDA 510(k) clearance on 2019-08-14 under approval number K190852. 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 Zurich Pressure Guidewire System Model 100?

Zurich Pressure Guidewire System Model 100 is a medical device that received FDA 510(k) clearance on 2019-08-14. It is manufactured by Zurich Medical, Inc.. The 510(k) number is K190852.

When was Zurich Pressure Guidewire System Model 100 approved by the FDA?

Zurich Pressure Guidewire System Model 100 received FDA 510(k) clearance on 2019-08-14, under approval number K190852.

What company makes Zurich Pressure Guidewire System Model 100?

Zurich Pressure Guidewire System Model 100 is manufactured by Zurich Medical, Inc..

What is the FDA product code for Zurich Pressure Guidewire System Model 100?

The FDA product code for Zurich Pressure Guidewire System Model 100 is DXO.

Related Clinical Trials

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Related PubMed Literature

PMID: 39892748 Long-term Safety and Performance of a Suprachoroidal Pressure Sensor System: Results of the EYEMATE-SC Trial Follow-up Study. Ophthalmology (2025)

Related Devices (Code: DXO)

K161263OptoMonitor IIOpsens, Inc. K161171PressureWire X GuidewireSt. Jude Medical, Inc. K171996TruWave Disposable Pressure TransducerEdwards Lifesciences, LLC K163376Mikro-Cath Pressure CatheterMillar, Inc. K180558PressureWire XSt. Jude Medical (Now Part of Abbott Medical) K193279Comet II Pressure GuidewireBoston Scientific Corporation

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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