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 IDK132420
510k NumberK132420
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 Received2013-08-05
Decision Date2013-09-19
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00856492005197 K132420 000
00856492005159 K132420 000
00856492005142 K132420 000

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