Instylla Microcatheter 1.2

Catheter, Continuous Flush

Instylla, Inc.

The following data is part of a premarket notification filed by Instylla, Inc. with the FDA for Instylla Microcatheter 1.2.

Pre-market Notification Details

Device IDK210808
510k NumberK210808
Device Name:Instylla Microcatheter 1.2
ClassificationCatheter, Continuous Flush
Applicant Instylla, Inc. 201 Burlington Road, North Building Bedford,  MA  01730
ContactJennifer Greer
CorrespondentJennifer Greer
Instylla, Inc. 201 Burlington Road, North Building Bedford,  MA  01730
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-03-17
Decision Date2021-04-15

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