Browse hierarchy: [Cardiovascular (CV)](/submissions/CV) → [Subpart B — Cardiovascular Diagnostic Devices](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices) → [21 CFR 870.1230](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1230) → DQE — Catheter, Oximeter, Fiber-Optic # DQE · Catheter, Oximeter, Fiber-Optic _Cardiovascular · 21 CFR 870.1230 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE ## Overview - **Product Code:** DQE - **Device Name:** Catheter, Oximeter, Fiber-Optic - **Regulation:** [21 CFR 870.1230](/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/870.1230) - **Device Class:** 2 - **Review Panel:** [Cardiovascular](/submissions/CV) - **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](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K172423.md) | PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter) | Edwards Lifescience, LLC | Feb 20, 2018 | SESE | | [K160645](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K160645.md) | PreSep Oligon Oximetry Catheter | Edwards Lifesciences, LLC | Jun 16, 2016 | SESE | | [K140129](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K140129.md) | PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER | Icu Medical, Inc. | Jul 2, 2014 | SESE | | [K110167](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K110167.md) | PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN) | Edwards Lifesciences, LLC | Feb 18, 2011 | SESE | | [K091268](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K091268.md) | HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS | Hospira, Inc. | Sep 18, 2009 | SESE | | [K062999](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K062999.md) | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN | Hospira, Inc. | Nov 3, 2006 | SESE | | [K061585](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K061585.md) | OPTICATH CENTRAL VENOUS OXIMETRY CATHETER | Hospira, Inc. | Oct 5, 2006 | SESE | | [K061450](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K061450.md) | HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS | Hospira, Inc. | Aug 4, 2006 | SESE | | [K061159](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K061159.md) | OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN | Hospira, Inc. | Jun 26, 2006 | SESE | | [K060093](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K060093.md) | PRESEP OLIGON OXIMETRY CATHETERS | Edwards Lifesciences, LLC | Apr 28, 2006 | SESE | | [K053609](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K053609.md) | PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR | Edwards Lifesciences, LLC | Feb 28, 2006 | SESE | | [K926450](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K926450.md) | EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH | Baxter Healthcare Corp | Feb 22, 1993 | SESE | | [K915073](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K915073.md) | MARQUETTE SV O2 MODULE | Marquette Electronics, Inc. | Dec 29, 1992 | SESE | | [K905458](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K905458.md) | SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER | Baxter Healthcare Corp | Feb 7, 1991 | SESE | | [K901736](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K901736.md) | OXIMETRY PROBE CATHETERS | Baxter Healthcare Corp | Sep 11, 1990 | SESE | | [K864745](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K864745.md) | POET OXIMETER | Criticare Systems, Inc. | Jun 2, 1987 | SESE | | [K820674](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K820674.md) | OPTICATH | Oximetrix, Inc. | Mar 25, 1982 | SESE | | [K781134](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K781134.md) | CATHETER, THERMAL DILUTION FIBEROPTIC | Oximetrix, Inc. | Aug 17, 1978 | SESE | | [K760234](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE/K760234.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE](https://fda.innolitics.com/submissions/CV/subpart-b%E2%80%94cardiovascular-diagnostic-devices/DQE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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