CD Leycom Pressure/Volume Catheters
FDA 510(k)Class II (US FDA 510(k))
by Cd Leycom BV
Identifiers
- 510(k) Number
- K031599 FDA 510(k)
- FDA Product Code
- DQO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1200 FDA 510(k)
- Regulation Number
- 870.1200 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
CD Leycom Pressure/Volume Catheters are diagnostic intravascular catheters used to measure pressure and volume within the left ventricle. They provide real-time hemodynamic data during cardiac catheterization procedures, enabling clinicians to assess left ventricular function.
These catheters are supplied sterile and are intended for single-use. They are compatible with the CFL 512 system and pressure interface module. The device is regulated under FDA 510(k) clearance (K031599) and is classified as a Special clearance type.
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: PV Loop Catheters - CD Leycom, PV Loop Medical Devices - CD Leycom, CD LEYCOM PRESSURE/VOLUME CATHETERS - Innolitics, Cd Leycom 7 Fr Pressure/Volume Catheter (10 Mm Electrode Spacing ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K031599 | Class II | Active |
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Manufacturer
- Manufacturer
- Cd Leycom BV
Sources (1)
- FDA 510(k) K031599 24 fields · synced Sep 22, 2026