# K062999: Opticath Central Venous Oximetry Probe with Seal with Heparin

- Pathway: 510(k) (Special)
- Applicant: Hospira, Inc.
- Decided: Nov 3, 2006 after 32 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.
No later device cites it as a predicate yet.
0 of 1 device 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) OPTICATH Central Venous Oximetry Probe with Fluidic Seal: named in the summary without a submission number

## Indications for use
The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is intended for measuring the oxygen saturation of blood. The OPTICATH® Central Venous Oximetry Probe with Fluidic Seal (Heparin Coated) is indicated for the continuous in vivo measurement of the oxyhemoglobin saturation of blood in the central venous system (ScvO₂) for monitoring hemodynamic status during metabolic, respiratory, cardiovascular, and/or other physiological system(s) compromise in accordance with hospital protocols or current Clinical Standards of Practice. The probe with fluidic seal is also indicated for pressure monitoring, and infusion of fluids.

Source page: https://510kreport.com/device/K062999
Methodology: https://510kreport.com/methodology