SOLITAIRE 2 REVASCULARIZATION DEVICE

Catheter, Thrombus Retriever

MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR

The following data is part of a premarket notification filed by Micro Therapeutics Dba Ev3 Neurovascular with the FDA for Solitaire 2 Revascularization Device.

Pre-market Notification Details

Device IDK123378
510k NumberK123378
Device Name:SOLITAIRE 2 REVASCULARIZATION DEVICE
ClassificationCatheter, Thrombus Retriever
Applicant MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
ContactLarry Boucher
CorrespondentLarry Boucher
MICRO THERAPEUTICS DBA EV3 NEUROVASCULAR 9775 TOLEDO WAY Irvine,  CA  92618
Product CodeNRY  
CFR Regulation Number870.1250 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeSpecial
3rd Party ReviewedNo
Combination ProductNo
Date Received2012-11-01
Decision Date2012-11-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00847536020733 K123378 000
00847536020726 K123378 000
00847536020719 K123378 000
00847536020702 K123378 000
00836462016408 K123378 000
00836462016392 K123378 000
00836462016385 K123378 000
00836462016378 K123378 000

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