The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Opticath Central Venous Oximetry Probe With Fluidic Seal With/without Heparin.
| Device ID | K061159 |
| 510k Number | K061159 |
| Device Name: | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | HOSPIRA, INC. 275 N. FIELD DR., BLDG. H-2 D-389 Lake Forest, IL 60045 -5045 |
| Contact | Thomas Kozma |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | Yes |
| Date Received | 2006-04-26 |
| Decision Date | 2006-06-26 |
| Summary: | summary |