Medical Device Manufacturer · US , Louisville , CO

Medivance, Inc.

12 submissions · 12 cleared · Since 2000
12
Total
12
Cleared
0
Denied

Medivance, Inc. — FDA 510(k) Submissions

Medivance, Inc. has submitted 12 FDA 510(k) premarket notifications since 2000, of which 12 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include System, Thermal Regulating, System, Hypothermia, Intravenous, Cooling, Continuous Measurement Thermometer . Use the specialty filter in the sidebar to narrow results.

12 devices
1–12 of 12
Arctic Sun Temperature Management System (Model 5000)
K251974 · DWJ System, Thermal Regulating · Cardiovascular
Oct 2025 120d
Arctic Sun Stat Temperature Management System
K243942 · DWJ System, Thermal Regulating · Cardiovascular
Apr 2025 131d
Arctic Sun Stat Temperature Management System
K200225 · DWJ System, Thermal Regulating · Cardiovascular
Feb 2020 29d
Arctic Sun Temperature Management System
K161602 · DWJ System, Thermal Regulating · Cardiovascular
Sep 2016 85d
Arctic Sun Temperature Management System, ArcticGel Pads (Universal, XXS, XS, S, M and L), Small Universal ArcticGel Pad, Neonatal ArcticGel Pad
K142702 · DWJ System, Thermal Regulating · Cardiovascular
Dec 2014 87d
HYBRID ARCTICGEL PAD
K120849 · DWJ System, Thermal Regulating · Cardiovascular
Jul 2012 122d
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR
K110956 · FLL Continuous Measurement... · General Hospital
Jul 2011 104d
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000
K101092 · DWJ System, Thermal Regulating · Cardiovascular
Jul 2010 87d
ARCTIC BLAST INTRAVENOUS FLUID CHILLER
K080899 · NCX System, Hypothermia,... · Neurology
Aug 2008 129d
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000
K071341 · DWJ System, Thermal Regulating · Cardiovascular
Aug 2007 81d
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200
K010338 · DWJ System, Thermal Regulating · Cardiovascular
Mar 2001 30d
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 100 CONTROL UNIT AND PATIENT ENERGY TRANSFER PADS
K002577 · DWJ System, Thermal Regulating · Cardiovascular
Oct 2000 69d
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