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510(k) Data Aggregation
K Number
K112335Device Name
BANTAM CATHETER (280MM BALLOON LENGTHS)
Manufacturer
CLEAR STREAM TECHNOLOGIES, LTD.
Date Cleared
2011-10-12
(61 days)
Product Code
DQY, LIT
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEAR STREAM 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 Bantam (280mm balloon lengths) catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018"). The balloon expands to a known diameter at specific pressure.
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K Number
K102035Device Name
SLEEK OTW PTA CATHETERS
Manufacturer
CLEAR STREAM TECHNOLOGIES, LTD.
Date Cleared
2010-12-01
(135 days)
Product Code
LIT, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEAR STREAM 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 Sleek OTW PTA Catheter is a standard over-the-wire PTA catheter. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (0.014"). The balloon expands to a known diameter at specific pressure.
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K Number
K100490Device Name
LITEPAC, MODEL 682
Manufacturer
CLEAR STREAM TECHNOLOGIES, LTD.
Date Cleared
2010-03-16
(25 days)
Product Code
LIT, DOY, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEAR STREAM 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 LitePAC PTA Catheter is a standard rapid exchange PTA catheter. The proximal end provides a mono luer hub connector which allows the attachment of an inflation device used to inflate and deflate the balloon through the outer lumen. The rapid exchange port is positioned at the transition area between the stiffer hypotube and the more flexible distal portion and facilitates single operator use for insertion into a 0.014" guidewire.
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K Number
K093139Device Name
BANTAM,48XXXXXX, 50XXXXXX
Manufacturer
CLEAR STREAM TECHNOLOGIES, LTD.
Date Cleared
2009-12-30
(86 days)
Product Code
LIT, DQY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
CLEAR STREAM 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 Bantam and Bantam & PTA Catheters are standard over-the-wire PTA catheters. The co-axial catheter has a balloon located near the distal tip. One lumen is used for inflation of the balloon, while the internal lumen allows access to the distal tip of the catheter for guidewire insertion (max 0.018" and 0.014"). The balloon expands to a known diameter at specific pressure.
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