The following data is part of a premarket notification filed by Hospira, Inc. with the FDA for Opticath Central Venous Oximetry Probe With Seal With Heparin.
| Device ID | K062999 |
| 510k Number | K062999 |
| Device Name: | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN |
| Classification | Catheter, Oximeter, Fiber-optic |
| Applicant | HOSPIRA, INC. 275 NORTH FIELD DR. DEPT. 389, BLDG. H2-2 Lake Forest, IL 60045 |
| Contact | Diane Rennpferd |
| Correspondent | Diane Rennpferd HOSPIRA, INC. 275 NORTH FIELD DR. DEPT. 389, BLDG. H2-2 Lake Forest, IL 60045 |
| Product Code | DQE |
| CFR Regulation Number | 870.1230 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-10-02 |
| Decision Date | 2006-11-03 |
| Summary: | summary |