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510(k) Data Aggregation
K Number
K210114Device Name
Rebar Micro Catheter
Manufacturer
Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular
Date Cleared
2021-02-16
(28 days)
Product Code
KRA, QJP
Regulation Number
870.1210Why did this record match?
Applicant Name (Manufacturer) :
Micro Therapeuatics, Inc. d/b/a ev3 Neurovascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Rebar™ Micro Catheter is intended for the delivery of interventional devices or contrast media into the vasculature of the peripheral and neuro anatomy.
Device Description
The Rebar" Micro Catheter is an endhole, single-lumen catheter designed to be introduced over a steerable guidewire into the vasculature. The proximal end of the catheter incorporates a standard luer adapter to facilitate the attachment of accessories. The catheter has a semi-rigid proximal shaft which transitions into the flexible distal shaft to facilitate the advancement of the catheter in the anatomy. Single or dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter is coated to increase lubricity.
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