DQE · Catheter, Oximeter, Fiber-Optic
Cardiovascular · 21 CFR 870.1230 · Class 2
Overview
| Product Code | DQE |
|---|---|
| Device Name | Catheter, Oximeter, Fiber-Optic |
| Regulation | 21 CFR 870.1230 |
| Device Class | Class 2 |
| Review Panel | Cardiovascular |
| 3rd-Party Reviewable | Yes |
Identification
A fiberoptic oximeter catheter is a device used to estimate the oxygen saturation of the blood. It consists of two fiberoptic bundles that conduct light at a desired wavelength through blood and detect the reflected and scattered light at the distal end of the catheter.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (19 of 19)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K172423 | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | Edwards Lifescience, LLC | Feb 20, 2018 | SESE |
| K160645 | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | Jun 16, 2016 | SESE |
| K140129 | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | Icu Medical, Inc. | Jul 2, 2014 | SESE |
| K110167 | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | Edwards Lifesciences, LLC | Feb 18, 2011 | SESE |
| K091268 | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | Hospira, Inc. | Sep 18, 2009 | SESE |
| K062999 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN | Hospira, Inc. | Nov 3, 2006 | SESE |
| K061585 | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER | Hospira, Inc. | Oct 5, 2006 | SESE |
| K061450 | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS | Hospira, Inc. | Aug 4, 2006 | SESE |
| K061159 | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN | Hospira, Inc. | Jun 26, 2006 | SESE |
| K060093 | PRESEP OLIGON OXIMETRY CATHETERS | Edwards Lifesciences, LLC | Apr 28, 2006 | SESE |
| K053609 | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | Feb 28, 2006 | SESE |
| K926450 | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | Baxter Healthcare Corp | Feb 22, 1993 | SESE |
| K915073 | MARQUETTE SV O2 MODULE | Marquette Electronics, Inc. | Dec 29, 1992 | SESE |
| K905458 | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | Baxter Healthcare Corp | Feb 7, 1991 | SESE |
| K901736 | OXIMETRY PROBE CATHETERS | Baxter Healthcare Corp | Sep 11, 1990 | SESE |
| K864745 | POET OXIMETER | Criticare Systems, Inc. | Jun 2, 1987 | SESE |
| K820674 | OPTICATH | Oximetrix, Inc. | Mar 25, 1982 | SESE |
| K781134 | CATHETER, THERMAL DILUTION FIBEROPTIC | Oximetrix, Inc. | Aug 17, 1978 | SESE |
| K760234 | OXIMETER, IN VIVO CATHETER | Oximetrix, Inc. | Aug 23, 1976 | SESE |
Top Applicants
- Hospira, Inc. — 5 clearances
- Edwards Lifesciences, LLC — 4 clearances
- Baxter Healthcare Corp — 3 clearances
- Oximetrix, Inc. — 3 clearances
- Criticare Systems, Inc. — 1 clearance
