CoraCross

Catheter, Percutaneous

Reflow Medical

The following data is part of a premarket notification filed by Reflow Medical with the FDA for Coracross.

Pre-market Notification Details

Device IDK210188
510k NumberK210188
Device Name:CoraCross
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)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-01-25
Decision Date2021-05-28

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00850025525053 K210188 000
00850025525046 K210188 000

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