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510(k) Data Aggregation
K Number
K190852Device Name
Zurich Pressure Guidewire System Model 100
Manufacturer
Zurich Medical Inc.
Date Cleared
2019-08-14
(134 days)
Product Code
DXO, DQK, DQX, DSK
Regulation Number
870.2870Why did this record match?
Applicant Name (Manufacturer) :
Zurich Medical Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Zurich Pressure Guidewire System is indicated to measure physiological parameters in the coronary and peripheral blood vessels and in the heart. Zurich Pressure Guidewire System is also indicated to direct a catheter through a blood vessel.
Device Description
The Zurich Pressure Guidewire System Model 100™ ("Zurich Pressure Guidewire System") consists of a 0.014" (0.36 mm) diameter, 180 cm long Interventional Guidewire with a high fidelity sensor located immediately beyond the 3 cm shapeable radiopaque tip and a uniquely paired Portable Display. The signals from the sensor can be used to measure blood pressures and calculate Fractional Flow Reserve (FFR). The Guidewire is connected to the Portable Display via the Handle. The distal end has hydrophilic coating. The Portable Display also has an AO Cable that may be used to connect to the Zurich Medical Accessory Cable for AO pressure signal.
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