HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS— 510(k) K091268

Clearance details

Applicant

Hospira, Inc.

Product code

Code DQE

Device class

Class 2

Regulation

21 CFR 870.1230

Advisory panel

Cardiovascular

Date received

2009-04-30

Decision date

2009-09-18

Decision

Substantially Equivalent

Clearance type

Special

Location

Lake Forest, IL, US

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• K140129 — PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER2014-07-02
• K110167 — PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)2011-02-18
• K062999 — OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN2006-11-03

• K161469 — Plum 360(TM) Infusion System with MedNet/ Smart Card Plug and Play Module2017-03-28
• 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

• Z-1997-2020 — 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 # 41401-23.Class II·Terminated·ICU Medical, Inc.·20200102
• Z-1998-2020 — 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 # 41401-25.Class II·Terminated·ICU Medical, Inc.·20200102
• Z-1999-2020 — 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 # 41406-23Class II·Terminated·ICU Medical, Inc.·20200102
• Z-2000-2020 — 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 # 41411-25Class II·Terminated·ICU Medical, Inc.·20200102
• Z-2001-2020 — 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 # 41414-23Class 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 K091268.