Volcano S5i Intravascular Ultracound Imaging And Pressure System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K113486 FDA 510(k)
- FDA Product Code
- IYO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.1560 FDA 510(k)
- Regulation Number
- 892.1560 FDA 510(k)
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Volcano S5I Intravascular Ultrasound Imaging and Pressure System is a diagnostic device classified as an intravascular ultrasound catheter system. It combines real-time ultrasound imaging with intravascular pressure measurement to visualize and assess coronary and peripheral arteries, aiding in the evaluation of plaque composition, vessel dimensions, and hemodynamic function during interventional procedures.
This system is designed for use in cardiac catheterization laboratories and interventional radiology settings. Supplied as a sterile, single-use device, it operates within MRI-safe parameters as defined by the manufacturer’s specifications. The system includes various catheter sizes and imaging probes, requiring proper storage under controlled conditions to maintain sterility and functionality. Its regulatory authorizations include FDA 510K clearance under Special Review and compliance with the Medical Device Directive (MDD)
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.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K113486 | Class II | Active |
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Manufacturer
- Manufacturer
- Volcano Corporation
Sources (2)
- FDA 510(k) K113486 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026