OPTICATH CENTRAL VENOUS OXIMETRY CATHETER— 510(k) K061585

Name: FDA 510(k) clearance K061585
Creator: U.S. Food and Drug Administration
Published: 2006-10-05

Substantially Equivalent

Hospira, Inc.

FDA 510(k) clearance K061585 for OPTICATH CENTRAL VENOUS OXIMETRY CATHETER, Substantially Equivalent on 2006-10-05. Applicant: Hospira, Inc.. Device class: 2.

Clearance details

Applicant: Hospira, Inc.
Product code: Code DQE
Device class: Class 2
Regulation: 21 CFR 870.1230
Advisory panel: Cardiovascular
Date received: 2006-06-07
Decision date: 2006-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lake Forest, IL, US

Download summary PDF View on FDA.gov ↗

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K161036 — Hospira Extension Set, Hospira Primary Set2017-01-06
K160492 — Hospira Sapphire Sets2016-12-06
K160870 — Hospira Administration Sets2016-06-01
K143612 — LifeCare PCA Infusion System2016-04-08

Recalls naming K061585

K-number listed on FDA's recall record

Z-2002-2020 — 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 # 50456-01Class II·Terminated·ICU Medical, Inc.·20200102

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K061585.

Data sourced from openFDA. This site is unofficial and independent of the FDA.