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510(k) Data Aggregation
K Number
K171268Device Name
Reverse 021 Micro Catheter, Reverse 027 Micro Catheter
Manufacturer
Date Cleared
2017-05-31
(30 days)
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
MicroTherapeutics, Inc. d/b/a ev3 Neurovascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Reverse™M Micro Catheter is intended for use in neuro, peripheral, and coronary vasculature for the infusion of diagnostic agents, such as contrast media, and therapeutic agents, such as occlusion coils.
Device Description
The Reverse™ Micro Catheter is a single lumen catheter designed to be introduced over a steerable guide wire to access small, tortuous vasculature. The semi-rigid proximal section transitions to a flexible distal tip to facilitate vessel navigation. The micro catheter incorporates a PTFE liner to facilitate movement or introduction of devices passed through its lumen. Dual radiopaque markers at the distal end facilitate fluoroscopic visualization. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability. The Reverse™ Micro Catheter incorporates a standard luer fitting to facilitate the attachment of ancillary devices. The catheter and included accessories (steam shaping mandrel and peel away introducer sheath) are provided sterile, nonpyrogenic, and are intended for single use only. To accommodate physician preference and anatomical variations, the Reverse™ Micro Catheter is available in two models, Reverse 021, with a 0.021" inner diameter (ID) and, Reverse 027, with a 0.027" ID.
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