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510(k) Data Aggregation
K Number
K080067Device Name
ISCIENCE INTERVENTIONAL OPHTHALMIC MICROCATHETER
Manufacturer
ISCIENCE INTERVENTIONAL
Date Cleared
2008-07-18
(190 days)
Product Code
MPA, HMX
Regulation Number
876.1500Why did this record match?
Applicant Name (Manufacturer) :
ISCIENCE INTERVENTIONAL
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The iScience Interventional Canaloplasty Microcatheter is indicated for fluid infusion and aspiration during surgery. The iScience Interventional Canaloplasty Microcatheter is indicated for catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma.
Device Description
The iScience Interventional Canaloplasty Microcatheter is a flexible microcatheter designed to allow atraumatic catheterization of spaces in the eye for infusion and aspiration of fluids during surgery. The device allows catheterization and viscodilation of Schlemm's canal to reduce intraocular pressure in adult patients with open angle glaucoma. The microcatheter incorporates an optical fiber to allow transmission of light to the microcatheter tip for surgical illumination and guidance. The device is provided sterile and is intended for single use.
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