# K060093: Presep Oligon Oximetry Catheters

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Apr 28, 2006 after 106 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
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Central Venous Oximetry Probe Catheter and Probe: named in the summary without a submission number
- (no number) Vantex Central Venous Catheters with Oligon material: named in the summary without a submission number
- (no number) Edslab Dual Lumen Regional Saturation Oximetry Catheter: named in the summary without a submission number

## Most influential descendants
- K160645: PreSep Oligon Oximetry Catheter (2016), 1 descendant of its own
- K110167: Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin) (2011), 1 descendant of its own
- K172423: PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (2018), 0 descendants of its own
- 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/K060093
Methodology: https://510kreport.com/methodology