Agile Devices Angler Steerable, Deflectable Microcatheter

Catheter, Continuous Flush

Agile Devices, Inc.

The following data is part of a premarket notification filed by Agile Devices, Inc. with the FDA for Agile Devices Angler Steerable, Deflectable Microcatheter.

Pre-market Notification Details

Device IDK211110
510k NumberK211110
Device Name:Agile Devices Angler Steerable, Deflectable Microcatheter
ClassificationCatheter, Continuous Flush
Applicant Agile Devices, Inc. 69 Fox Hill Road Wellesley,  MA  02481
ContactStephen Tully
CorrespondentStephen Tully
Strategic Device Solutions LLC 20 Lawton Lane Foxborough,  MA  02035
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-04-14
Decision Date2022-01-07

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