# K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)

- Pathway: 510(k) (Special)
- Applicant: Edwards Lifesciences, LLC
- Decided: Feb 18, 2011 after 29 days
- Product code: DQE (Catheter, Oximeter, Fiber-Optic)
- Device class: 2
- Regulation: 21 CFR 870.1230
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K935170 (1994). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060093: Presep Oligon Oximetry Catheters, Edwards Lifesciences, LLC (2006) Summary page 1.
- K100739: Volumeview System, Models VLV520FT6R, VLV520FT8R, VLV520FT6R5, Edwards Lifesciences, LLC (2010) Summary page 1.

## Most influential descendants
- K113565: Multi-Med Central Venous Catheters (CVCS), with and Without Heparin Vantex Central Venous Catheters (CVCS), with Heparin (2012), 0 descendants of its own

## Indications for use
The PreSep Oligon Oximetry Catheters are indicated for hemodynamic monitoring through blood sampling, pressure monitoring and oxygen saturation measurements.

Source page: https://510kreport.com/device/K110167
Methodology: https://510kreport.com/methodology