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510(k) Data Aggregation
K Number
K082646Device Name
OPTIMUS 0.035 PTA BALLOON DILATATION CATHETER
Manufacturer
Date Cleared
2008-11-03
(53 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
USCI IRELAND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.
Device Description
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque marker bands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.
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K Number
K072156Device Name
OPTIMUS 0.035 INCH PTA BALLOON DILATATION CATHETER
Manufacturer
Date Cleared
2007-11-09
(98 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
USCI IRELAND
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The OPTIMUS 0.035" PTA Balloon Dilation Catheter is intended to dilate stenoses in the Illiac, Femoral, Popliteal and Renal arteries.
Device Description
The OPTIMUS 0.035" PTA Balloon Dilatation Catheter is a two lumen catheter with a distal inflatable balloon. One lumen is used for inflation of the balloon with contrast medium; the other lumen permits the use of a guide wire to facilitate advancement of the catheter to and through the stenosis to be dilated. Two radiopaque markerbands indicate the dilatating section of the balloon and aid in the balloon placement. The marker bands also indicate the stated nominal length of the balloon. The catheter tip is designed to ease entry into the indicated arteries and to facilitate the crossing of tight stenoses.
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