SwiftNINJA Steerable Microcatheter

Catheter, Continuous Flush

Merit Medical Systems, Inc.

The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Swiftninja Steerable Microcatheter.

Pre-market Notification Details

Device IDK211525
510k NumberK211525
Device Name:SwiftNINJA Steerable Microcatheter
ClassificationCatheter, Continuous Flush
Applicant Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
ContactLuke Meidell
CorrespondentLuke Meidell
Merit Medical Systems, Inc. 1600 West Merit Parkway South Jordan,  UT  84095
Product CodeKRA  
CFR Regulation Number870.1210 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2021-05-17
Decision Date2021-07-16

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