Riptide Aspiration System (Riptide Large Bore Aspiration System)

Catheter, Thrombus Retriever

Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular

The following data is part of a premarket notification filed by Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular with the FDA for Riptide Aspiration System (riptide Large Bore Aspiration System).

Pre-market Notification Details

Device IDK183185
510k NumberK183185
Device Name:Riptide Aspiration System (Riptide Large Bore Aspiration System)
ClassificationCatheter, Thrombus Retriever
Applicant Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
ContactNancy Drew
CorrespondentNancy Drew
Micro Therapeutics, Inc. D/b/a Ev3 Neurovascular 9775 Toledo Way Irvine,  CA  92618
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2018-11-19
Decision Date2018-12-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536034839 K183185 000
00763000299439 K183185 000

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