FDA 510(k) Applications Submitted by LYNNE ARONSON
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K160662 |
03/09/2016 |
Surefire Infusion System |
SUREFIRE MEDICAL, INC |
| K140034 |
01/07/2014 |
SUREFIRE GUIDING CATHETER |
SUREFIRE MEDICAL, INC. |
| K010338 |
02/05/2001 |
ARTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 200 |
MEDIVANCE, INC. |
| K000480 |
02/14/2000 |
ACTIVE ELECTRODE MONITORING SYSTEM |
ELECTROSCOPE, INC. |
| K180677 |
03/15/2018 |
Surefire Spark Infusion System |
Surefire Medical, Inc. |
| K120849 |
03/20/2012 |
HYBRID ARCTICGEL PAD |
MEDIVANCE, INC. |
| K080899 |
03/31/2008 |
ARCTIC BLAST INTRAVENOUS FLUID CHILLER |
MEDIVANCE, INC. |
| K110956 |
04/05/2011 |
MEDIVANCE NASOGASTRIC TUBE TEMPERATURE SENSOR |
MEDIVANCE, INC. |
| K101092 |
04/20/2010 |
ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 5000 |
MEDIVANCE, INC. |
| K171355 |
05/09/2017 |
Surefire Precision Infusion System |
Surefire Medical, Inc. |
| K071341 |
05/14/2007 |
MODIFICATION TO ARCTIC SUN TEMPERATURE MANAGEMENT SYSTEM, MODEL 2000 |
MEDIVANCE, INC. |
| K162359 |
08/23/2016 |
Surefire Guiding Catheter |
Surefire Medical, Inc. |
| K993614 |
10/25/1999 |
FAS ENDOLUMINAL BRUSH |
FAS MEDICAL LTD. |
| K143588 |
12/18/2014 |
Surefire Infusion System 021 |
SUREFIRE MEDICAL, INC |
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