Identifiers
- 510(k) Number
- K111395 FDA 510(k)
- FDA Product Code
- DQX FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1330 FDA 510(k)
- Regulation Number
- 870.1330 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The PRIMEWIRE PRESTIGE PLUS is a steerable pressure guide wire with a pressure transducer mounted 3 cm proximal to the tip, used for measuring distal pressure during vascular procedures. It has a diameter of 0.014 inches (0.36 mm) and is designed for use with SmartMap, s5 Family, and ComboMap systems.
The device is supplied in lengths of 185 cm or 300 cm and is intended for single use in clinical settings. It is regulated under FDA 510(k) authorization with product code DQX and was cleared under the substantially equivalent pathway. Storage conditions and sterility status are not specified in the available data.
Frequently asked questions
What clinical purpose does the Primewire Prestige Plus serve?
It is designed to measure distal vascular pressure during interventional procedures, allowing clinicians to assess blood flow dynamics in real time while navigating the coronary or peripheral vasculature.
In what lengths is the Primewire Prestige Plus supplied and can it be reused?
The guide wire is provided in two lengths—185 cm and 300 cm—to suit different procedural needs, and it is intended for single‑use only, ensuring sterility and performance for each case.
How is the pressure transducer positioned on the Primewire Prestige Plus?
A pressure transducer is mounted 3 cm proximal to the distal tip of the 0.014‑inch (0.36 mm) wire, enabling accurate pressure readings right at the measurement site while maintaining steerability.
Which imaging systems are compatible with the Primewire Prestige Plus?
The device is compatible with Volcano’s SmartMap, s5 Family, and ComboMap systems, allowing seamless integration into existing workflow for pressure mapping and visualization during 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: Volcano Announces Global Launch of PrimeWire Prestige® PLUS Pressure ..., PDF 510 (K) Summary AUG 2011 PrimeWire PRESTIGE®V Plus Pressure Guide Wire ..., Volcano Announces Global Launch of PrimeWire Prestige® PLUS Pressure ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K111395 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (1)
- FDA 510(k) K111395 24 fields · synced Sep 24, 2026