WINGMAN EXTENDABLE TIP SUPPORT CATHETER

Catheter, Percutaneous

REFLOW MEDICAL

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

Pre-market Notification Details

Device IDK120178
510k NumberK120178
Device Name:WINGMAN EXTENDABLE TIP SUPPORT CATHETER
ClassificationCatheter, Percutaneous
Applicant REFLOW MEDICAL 1003 Calle Sombra San Clemente,  CA  92673
ContactRebecca K Pine
CorrespondentRebecca K Pine
REFLOW MEDICAL 1003 Calle Sombra San Clemente,  CA  92673
Product CodeDQY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-01-20
Decision Date2012-02-08
Summary:summary

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