# K160645: PreSep Oligon Oximetry Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Edwards Lifesciences, LLC
- Decided: Jun 16, 2016 after 101 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: 9 generations back to K001901 (2000). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
4 of 27 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)
- K071538: Arrow, Arrowg+Ard and Arrowg+Ard Blue Plus Pressure Injectable Central Venous Catheter, Arrow International, Inc. (2007) Summary page 4.

## Most influential descendants
- K172423: PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) (2018), 0 descendants of its own

## Indications for use
The pressure injectable PreSep Oligon Oximetry Catheters are indicated for short term (< 30 days) hemodynamic monitoring through blood sampling, infusion of solutions, continuous monitoring of oxygen saturation measurements, pressure injection of contrast media and central venous pressure monitoring. When used for pressure injection of contrast media do not exceed the maximum indicated flow rate for each catheter lumen. The maximum pressure of power injector equipment used with the pressure injectable PreSep Oligon Oximetry Catheter may not exceed 400psi.

Source page: https://510kreport.com/device/K160645
Methodology: https://510kreport.com/methodology