Product Code: DQE FDA class 2 21 CFR 870.1230

Catheter, Oximeter, Fiber-Optic

Cardiovascular

The Fiber-Optic Oximeter Catheter is a cardiovascular diagnostic device that measures oxygen saturation in the blood by transmitting and receiving light through fiber-optic strands during intravascular procedures. It is classified as an FDA Class 2 device, indicating moderate risk, and requires 510(k) premarket notification before marketing. The product code is DQE and it is regulated under 21 CFR 870.1230 within the Cardiovascular medical specialty. This device is eligible for third-party 510(k) review.

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510(k)s

FEI Numbers

Registration Numbers

Unique Applicants

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Basic Information

Product Code: DQE
Device Class: FDA class 2
Regulation Number: 870.1230
Medical Specialty: Cardiovascular
Review Panel: CV
Submission Type: 1

Device Characteristics

✗

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✓

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 19 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K172423	PediaSat Oximetry Catheter, PreSep Oligon Oximetry Catheter, Edwards Oximetry Central Venous Catheter (previously PreSep Oximetry Catheter)	Feb 20, 2018	Substantially Equivalent	Edwards Lifescience, LLC
K160645	PreSep Oligon Oximetry Catheter	Jun 16, 2016	Substantially Equivalent	Edwards Lifesciences, LLC
K140129	PICCOX PERIPHERALLY INSERTED PRESSURE INJECTABLE, CENTRAL VENOUS OXIMETRY CATHETER	Jul 02, 2014	Substantially Equivalent	Icu Medical, Inc.
K110167	PRESEP OLIGON OXIMETRY CATHETERS (16 CM, W/HEPARIN), (20CM, W/HEPARIN)	Feb 18, 2011	Substantially Equivalent	Edwards Lifesciences, LLC
K091268	HOSPIRA LATEX-FREE CRITICAL CARE AND ADVANCED SENSOR CATHETERS	Sep 18, 2009	Substantially Equivalent	Hospira, Inc.
K062999	OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH SEAL WITH HEPARIN	Nov 03, 2006	Substantially Equivalent	Hospira, Inc.
K061585	OPTICATH CENTRAL VENOUS OXIMETRY CATHETER	Oct 05, 2006	Substantially Equivalent	Hospira, Inc.
K061450	HOSPIRA LATEX-FREE ADVANCED SENSOR CATHETERS; HOSPIRA LATEX-FREE CRITICAL CARE CATHETERS	Aug 04, 2006	Substantially Equivalent	Hospira, Inc.
K061159	OPTICATH CENTRAL VENOUS OXIMETRY PROBE WITH FLUIDIC SEAL WITH/WITHOUT HEPARIN	Jun 26, 2006	Substantially Equivalent	Hospira, Inc.
K060093	PRESEP OLIGON OXIMETRY CATHETERS	Apr 28, 2006	Substantially Equivalent	Edwards Lifesciences, LLC
K053609	PRESEP AND PEDIASAT OXIMETRY CATHETERS AND VIGILEO ARTERIAL PRESSURE CARDIAC OUTPUT/OXIMETRY MONITOR	Feb 28, 2006	Substantially Equivalent	Edwards Lifesciences, LLC
K926450	EDSLAB(R) DUAL LUMEN REGION SATUR OXIMETRY CATH	Feb 22, 1993	Substantially Equivalent	Baxter Healthcare Corp
K915073	MARQUETTE SV O2 MODULE	Dec 29, 1992	Substantially Equivalent	Marquette Electronics, Inc.
K905458	SWAN-GANZ(R) FLOW DIRECT OXIMETRY/THERMOD CATHER	Feb 07, 1991	Substantially Equivalent	Baxter Healthcare Corp
K901736	OXIMETRY PROBE CATHETERS	Sep 11, 1990	Substantially Equivalent	Baxter Healthcare Corp
K864745	POET OXIMETER	Jun 02, 1987	Substantially Equivalent	Criticare Systems, Inc.
K820674	OPTICATH	Mar 25, 1982	Substantially Equivalent	Oximetrix, Inc.
K781134	CATHETER, THERMAL DILUTION FIBEROPTIC	Aug 17, 1978	Substantially Equivalent	Oximetrix, Inc.
K760234	OXIMETER, IN VIVO CATHETER	Aug 23, 1976	Substantially Equivalent	Oximetrix, Inc.