510(k) K061585 ยท DQE Catheter, Oximeter, Fiber-Optic
OPTICATH CENTRAL VENOUS OXIMETRY CATHETER
| Applicant | Hospira, Inc., Lake Forest IL, US |
| Decision | Substantially Equivalent, Oct 5, 2006 |
| Received | Jun 7, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K061585
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 2, 2020 | ICU Medical, Inc. Central Venous Catheters are indicated for the assessment of hemodynamic status through right atrial, right ventricular, and pulmonary artery and/or wedge pressure monitoring for patients. Model # 504 Terminated |
DQE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.