SpeX LP Support Catheter

Catheter, Percutaneous

Reflow Medical

The following data is part of a premarket notification filed by Reflow Medical with the FDA for Spex Lp Support Catheter.

Pre-market Notification Details

Device IDK200094
510k NumberK200094
Device Name:SpeX LP Support Catheter
ClassificationCatheter, Percutaneous
Applicant Reflow Medical 208 Avenida Fabricante #100 San Clemente,  CA  92672
ContactKrystal Santiago
CorrespondentKrystal Santiago
Reflow Medical 208 Avenida Fabricante #100 San Clemente,  CA  92672
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyCardiovascular
510k Review PanelCardiovascular
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-16
Decision Date2020-03-18

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