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510(k) Data Aggregation
K Number
K123831Device Name
OPHTACATH KIT
Manufacturer
FRANCE CHIRURGAE INSTRUMENTATION
Date Cleared
2013-07-29
(229 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
FRANCE CHIRURGAE INSTRUMENTATION
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The OphtaCath® Unilateral Kits (2-mm and 3-mm) are intended for use during dilation of the obstructed nasolacrimal duct to treat epiphora. For patients older than 12 months but under 30 months, the recommended catheter is the 2 mm balloon diameter. For patients 30 months and older, the recommended catheter is the 3 mm balloon diameter.
Device Description
The OphtaCath® lacrimal duct catheter is a sterile and single-use balloon catheter consisting of a semi-flexible stainless steel stylet covered by PBX tubing that ends with a nylon balloon. The balloon is covered by a protective polyethylene sleeve. The balloon is designed to be inflated to a known diameter and length at the specified pressure. Markings are placed at 10 mm and 15 mm · proximal to the working portion of the balloon. The overall length of the catheter is approximately 240 mm long. The catheter is available in a 2 mm inflated diameter. The 2 mm balloon has a length of 13 mm and a diameter of 0.90 mm before inflation. The 3 mm balloon has a length of 15 mm and a diameter of 1.0 mm before inflation. The Flamingo Inflation Device is an accessory to the OphtaCath®, and is a sterile, single-use inflation device for dilating the balloon catheter, monitoring balloon pressure, and deflating the balloon postoperatively. The OphtaCath® is sold as a unilateral kit that contains one 2 mm or 3 mm balloon catheter and an inflation device (OphtaCath® Unilateral Kits, 2-mm and 3-mm).
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