SOLEX CATHETER, MODEL SL2593

System, Hypothermia, Intravenous, Cooling

ALSIUS CORP.

The following data is part of a premarket notification filed by Alsius Corp. with the FDA for Solex Catheter, Model Sl2593.

Pre-market Notification Details

Device IDK081936
510k NumberK081936
Device Name:SOLEX CATHETER, MODEL SL2593
ClassificationSystem, Hypothermia, Intravenous, Cooling
Applicant ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine,  CA  92618
ContactJohn Riolo
CorrespondentJohn Riolo
ALSIUS CORP. 15770 LAGUNA CANYON, SUITE 150 Irvine,  CA  92618
Product CodeNCX  
CFR Regulation Number870.5900 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2008-07-07
Decision Date2008-08-13
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00849111075541 K081936 000
00849111075312 K081936 000
00849111075305 K081936 000
00849111075169 K081936 000
00849111075152 K081936 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.