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Presep Oligon Oximetry Catheters (16 cm, W/Heparin), (20CM, W/Heparin)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K110167

by Edwards Lifesciences LLC

Identifiers

510(k) Number
K110167 FDA 510(k)
FDA Product Code
DQE FDA 510(k)
Models / Variants
20cm FDA 510(k)
W FDA 510(k)
Heparin FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1230 FDA 510(k)
Regulation Number
870.1230 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Presep Oligon Oximetry Catheters are fiber-optic catheters designed for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements. These catheters are intended for continuous monitoring of central venous oxygen saturation (ScvO2) to detect tissue hypoxia early in critically ill patients.

The device is available in 16 cm and 20 cm lengths with heparin coating. It is a Class II cardiovascular device cleared under FDA 510(k) K110167. The catheters are supplied sterile and are intended for single use in clinical settings requiring hemodynamic monitoring.

Frequently asked questions

What are Presep Oligon Oximetry Catheters used for?

These fiber-optic catheters are designed for hemodynamic monitoring through blood sampling, pressure monitoring, and oxygen saturation measurements. They specifically monitor central venous oxygen saturation (ScvO2) to detect tissue hypoxia early in critically ill patients.

What sizes are available for the Presep Oligon Oximetry Catheters?

The catheters are available in two lengths: 16 cm and 20 cm, both with heparin coating. These different lengths allow clinicians to select the appropriate size based on patient needs and clinical requirements.

Are the Presep Oligon Oximetry Catheters reusable or single-use?

The catheters are supplied sterile and are intended for single use only. They should not be reused or resterilized as this could compromise device integrity and patient safety.

What is the regulatory status of the Presep Oligon Oximetry Catheters?

This is a Class II cardiovascular device cleared under FDA 510(k) K110167. The clearance was granted in 2011 after determining the device is substantially equivalent to other legally marketed devices.

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: Presep Oligon Oximetry Catheters (16 Cm, W/Heparin), (20cm, W/Heparin ..., Presep Oligon Oximetry Catheters (16 Cm, W/Heparin), (20cm, W/Heparin), PreSep Catheter - Edwards Lifesciences - PDF Catalogs | Technical ..., K110167 FDA 510 (k) - PRESEP OLIGON OXIMETRY CATHETERS (16 CM

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Edwards Lifesciences LLC
FDA Applicant
Edwards Lifesciences, LLC

Sources (1)

  • FDA 510(k) K110167 24 fields · synced Oct 6, 2026