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510(k) Data Aggregation
K Number
K142914Device Name
DacryoCATH
Manufacturer
ARMADILLO BIOMEDICAL, LLC
Date Cleared
2015-01-12
(97 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ARMADILLO BIOMEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
a. The 2MM catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
Device Description
The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and nylon balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length Of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.
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K Number
K113508Device Name
DACRYOCATH
Manufacturer
ARMADILLO BIOMEDICAL, LLC
Date Cleared
2012-08-31
(277 days)
Product Code
OKS
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
ARMADILLO BIOMEDICAL, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The lacrimal duct catheter is intended for use during dilation of the obstructed nasolacrimal duct.
The lacrimal duct catheter is indicated for use during dilation of the obstructed nasolacrimal duct in the following populations:
- a. The 2mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct obstruction in patients over 12 months of age and under 30 months of age.
- b. The 3 mm catheter is indicated for use during dilation of the obstructed nasolacrimal duct in children over 30 months of age.
- c. The 5mm catheter is indicated for use in adults during dilation of a lacrimal duct obstruction or blocked dacryocystorhinostomy ostium as a result of the following: functional or complete nasolacrimal duct obstruction, dacryocystitis, or failed dacryocystorhinostomy.
Device Description
The lacrimal duct catheter is a sterile, single use, non-pyrogenic disposable balloon catheter consisting of a semi-flexible stainless steel hypotube core and polyethylene terephthalate balloon tubing. The balloon is designed to inflate to a known diameter and length at the specific pressure. Markings are present 10 and 15 mm proximal to the beginning of the working portion of the balloon, which helps indicate when the balloon is placed correctly in the lacrimal system. The overall length of the catheter is 6 inches (15.24 cm) long. There is an opening on the distal end of the catheter hypotube to accommodate irrigation solutions. The Y-hub on the proximal end of the catheter has a luer port for inflation of the balloon catheter (labeled "inflation" with a red band) and a second luer port for irrigation through the balloon catheter (labeled "irrigation"). The balloon catheter is available in a 2 mm and 3 mm inflated diameter. The 3 mm balloon has a length of 15 mm and a deflated profile of approximately 1.1 mm. The 2 mm balloon has a length of 15 mm and a deflated profile of approximately 1.0 mm. The balloon has a 5 mm inflated diameter and a length of 10 mm. The deflated profile of the 5 mm balloon is approximately 1.2 mm.
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