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510(k) Data Aggregation
K Number
K101361Device Name
REEFLEX PTA CATHETER
Manufacturer
CLEARSTREAM TECHNOLOGIES, LTD.
Date Cleared
2010-08-04
(82 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEARSTREAM TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Balloon dilatation of the femoral, popliteal and infra popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Device Description
The ReeFlex™ is a balloon dilation catheter for angioplasty. It consists of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut. A heat shrinkable layer is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.
The balloon material is a Nylon blend. Low profile radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.
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K Number
K083596Device Name
REEKROSS FAMILY OR OTW PTA CATHETERS
Manufacturer
CLEARSTREAM TECHNOLOGIES, LTD.
Date Cleared
2009-03-02
(87 days)
Product Code
DQY, LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEARSTREAM TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Device Description
The ReeKross family of over the wire PTA catheters are a balloon dilation catheter for angioplasty. They consist of a stainless steel guidewire shaft that extends from the proximal hub to the distal tip of the catheter. This stainless steel shaft has a spiral cut positioned at its distal end. The spiral cut is laser cut and passivated following completion. A polymer bodybond material is used to seal the spiral cut and ensure that the contrast solution remains in the inflation lumen only and does not leak into the guidewire lumen. This bodybond material is fused onto the outside diameter of the stainless steel shaft. A copolymer inflation lumen extends from the proximal hub of the catheter to the proximal shoulder of the balloon. The lumen of the shaft is used for the purpose of inflating and deflating the balloon. This outer is thermally fused to the balloon's proximal shoulder.
The balloon material is a Nylon/Pebax blend. Low Profile Platinum Radiopaque bands are used to locate the balloon under fluoroscopy. These bands are swaged onto the bodybond material sealing the spiral cut section of the guidewire lumen.
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K Number
K072947Device Name
SAVVY LONG AND SLEEK PERIPHERAL TRANSLUMINAL ANGIOPLASTY (PTA) CATHETERS
Manufacturer
CLEARSTREAM TECHNOLOGIES, LTD.
Date Cleared
2008-02-08
(113 days)
Product Code
LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEARSTREAM TECHNOLOGIES, LTD.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Balloon dilatation of the femoral, popliteal and infra-popliteal arteries. These catheters are not designed to be used in the coronary arteries.
Device Description
A family of semi-compliant coaxial design catheters in various sizes. Each catheter has a balloon mounted on its distal tip. A hub/"Y" connector consists of a through lumen, allowing the catheter to track over a guidewire, and a balloon port used to inflate the balloon. To locate the balloon under fluoroscopy platinum iridium bands are provided at the shoulders of the balloon for all sizes. The proximal end of the catheter is provided with a transparent hub which allows easy observation of air bubbles. The hub is designed to facilitate easy removal of air bubbles during the preparation of the balloon.
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