Zurich Pressure Guidewire System Model 100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K190852 FDA 510(k)
- FDA Product Code
- DXO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.2870 FDA 510(k)
- Regulation Number
- 870.2870 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Zurich Pressure Guidewire System Model 100 is a transducer, pressure, catheter tip guidewire designed for intravascular pressure measurement. It integrates a distal pressure sensor within a 0.014-inch diameter guidewire, enabling real-time assessment of coronary or peripheral vessel pressures during interventional procedures.
This device is supplied as a single-use, reusable guidewire system intended for use in catheterization laboratories. It requires no special storage conditions and is compatible with standard MRI environments. Authorized under FDA 510(k) clearance (K190852) as substantially equivalent, it adheres to regulatory classification DXO (Class II) under 21 CFR 870.2870. The system is manufactured by Zurich Medical Inc., Plymouth, MN.
Frequently asked questions
What is the primary use of the Zurich Pressure Guidewire System Model 100 in clinical settings?
The Zurich Pressure Guidewire System Model 100 is designed for intravascular pressure measurement during interventional procedures. It integrates a distal pressure sensor within a 0.014-inch diameter guidewire, allowing real-time assessment of coronary or peripheral vessel pressures. This helps clinicians evaluate pressure gradients and guide decisions during catheterization.
Is the Zurich Pressure Guidewire System Model 100 intended for single-use or reusable applications?
The Zurich Pressure Guidewire System Model 100 is explicitly labeled as a single-use device, despite being described as a reusable guidewire system in the regulatory filing. Clinicians should follow manufacturer guidelines to ensure proper use and disposal to maintain safety and accuracy.
What storage conditions are required for the Zurich Pressure Guidewire System Model 100?
The device requires no special storage conditions, meaning it can be stored under standard laboratory or clinical environments without additional precautions. This makes it convenient for use in catheterization labs without extra logistical concerns.
Can the Zurich Pressure Guidewire System Model 100 be used in MRI environments?
Yes, the Zurich Pressure Guidewire System Model 100 is explicitly stated to be compatible with standard MRI environments, ensuring it can be used in procedures where magnetic resonance imaging may be involved or nearby.
How was the regulatory pathway for the Zurich Pressure Guidewire System Model 100 determined?
The device was cleared through the FDA 510(k) pathway under Traditional Review, with a decision of Substantially Equivalent (SESE) by the Cardiovascular (CV) Advisory Committee. It falls under Class II (DXO) regulatory classification (21 CFR 870.2870) for transducers, pressure, catheter tip guidewires, reflecting its intended use in cardiovascular procedures.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Guidewire | Zurich Medical, Guidewire | Zurich Medical, Zurich 100 Pressure Guidewire System - Medical XPRT, Zurich Pressure Guidewire System Model 100 (K190852) — FDA 510 (k ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K190852 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Zurich Medical Inc.
- FDA Applicant
- Zurich Medical, Inc.
Sources (1)
- FDA 510(k) K190852 24 fields · synced Sep 19, 2026