SOLITAIRE 2 REVASCULARIZATION DEVICE

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 Solitaire 2 Revascularization Device.

Pre-market Notification Details

Device IDK141491
510k NumberK141491
Device Name:SOLITAIRE 2 REVASCULARIZATION DEVICE
ClassificationCatheter, Thrombus Retriever
Applicant MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
ContactLarry Boucher
CorrespondentLarry Boucher
MICRO THERAPEUTICS, INC. D/B/A EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2014-06-05
Decision Date2014-10-22
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536018464 K141491 000

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