Catheter, Oximeter, Fiber-Optic
FDA product code DQE · Class II (moderate risk) · 21 CFR 870.1230 · Cardiovascular
19510(k) clearances
0PMA approvals
14recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central…DQE · Traditional | Edwards Lifescience, LLC | 02/20/2018SE |
| K160645 | PreSep Oligon Oximetry CatheterDQE · Traditional | Edwards Lifesciences, LLC | 06/16/2016SE |
| K140129 | Piccox Peripherally Inserted Pressure Injectable, Central Venous Oximetry CatheterDQE · Traditional | Icu Medical, Inc. | 07/02/2014SE |
| K110167 | Presep Oligon Oximetry Catheters (16 CM, W/Heparin), (20CM, W/Heparin)DQE · Special | Edwards Lifesciences, LLC | 02/18/2011SE |
| K091268 | Hospira Latex-Free Critical Care and Advanced Sensor CathetersDQE · Special | Hospira, Inc. | 09/18/2009SE |
| K062999 | Opticath Central Venous Oximetry Probe with Seal with HeparinDQE · Special | Hospira, Inc. | 11/03/2006SE |
| K061585 | Opticath Central Venous Oximetry CatheterDQE · Traditional | Hospira, Inc. | 10/05/2006SE |
| K061450 | Hospira Latex-Free Advanced Sensor Catheters; Hospira Latex-Free Critical Care CathetersDQE · Traditional | Hospira, Inc. | 08/04/2006SE |
| K061159 | Opticath Central Venous Oximetry Probe with Fluidic Seal With/Without HeparinDQE · Traditional | Hospira, Inc. | 06/26/2006SE |
| K060093 | Presep Oligon Oximetry CathetersDQE · Traditional | Edwards Lifesciences, LLC | 04/28/2006SE |
| K053609 | Presep and Pediasat Oximetry Catheters and Vigileo Arterial Pressure Cardiac…DQE · Traditional | Edwards Lifesciences, LLC | 02/28/2006SE |
| K926450 | Edslab(R) Dual Lumen Region Satur Oximetry CathDQE · Traditional | Baxter Healthcare Corp | 02/22/1993SE |
| K915073 | Marquette SV O2 ModuleDQE · Traditional | Marquette Electronics, Inc. | 12/29/1992SE |
| K905458 | Swan-Ganz(R) Flow Direct Oximetry/Thermod CatherDQE · Traditional | Baxter Healthcare Corp | 02/07/1991SE |
| K901736 | Oximetry Probe CathetersDQE · Traditional | Baxter Healthcare Corp | 09/11/1990SE |
| K864745 | Poet OximeterDQE · Traditional | Criticare Systems, Inc. | 06/02/1987SE |
| K820674 | OpticathDQE · Traditional | Oximetrix, Inc. | 03/25/1982SE |
| K781134 | Catheter, Thermal Dilution FiberopticDQE · Traditional | Oximetrix, Inc. | 08/17/1978SE |
| K760234 | Oximeter, in Vivo CatheterDQE · Traditional | Oximetrix, Inc. | 08/23/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2283-2021 Class II | Edwards PediaSat Oximetry Catheter Set, REF: XT3515SJ, Exterior Diameter 5.5F, Usable…There is a potential for internal leaks within catheters. | Edwards Lifesciences, LLC | 07/09/2021Terminated |
| Z-2282-2021 Class II | Edwards PediaSat Oximetry Catheter Set, REF: XT358KTP, Exterior Diameter 5.5F, Usable…There is a potential for internal leaks within catheters. | Edwards Lifesciences, LLC | 07/09/2021Terminated |
| Z-2281-2021 Class II | Edwards PediaSat Oximetry Catheter Set, REF: XT358SP, Exterior Diameter 5.5F (1.83 mm)…There is a potential for internal leaks within catheters. | Edwards Lifesciences, LLC | 07/09/2021Terminated |
| Z-2280-2021 Class II | Edwards PediaSat Oximetry Catheter Kit, REF: XT358SJ, Usable Length 8 cm, Number of…There is a potential for internal leaks within catheters. | Edwards Lifesciences, LLC | 07/09/2021Terminated |
| Z-2279-2021 Class II | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515SP, Exterior Diameter 5.5F (1.83 mm)…There is a potential for internal leaks within catheters. | Edwards Lifesciences, LLC | 07/09/2021Terminated |
| Z-2278-2021 Class II | Edwards PediaSat Oximetry Catheter Kit, REF: XT3515KTP, Exterior Diameter 5.5F (1.83…There is a potential for internal leaks within catheters. | Edwards Lifesciences, LLC | 07/09/2021Terminated |
| Z-2007-2020 Class II | Sterile Oxymetry Oligon Catheter Kit. Pressure injectable. REF/UDI:XA3816SAFKT/…Sterile catheter kit packaging compromised. | Edwards Lifesciences, LLC | 03/27/2020Terminated |
| Z-2002-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |
| Z-2001-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |
| Z-2000-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |
| Z-1999-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |
| Z-1998-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |
| Z-1997-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |
| Z-1996-2020 Class II | Central Venous Catheters are indicated for the assessment of hemodynamic status through…Inability for the guidewire to pass through the needles included with the catheter kits. | ICU Medical, Inc. | 01/02/2020Terminated |