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Found 5 results
510(k) Data Aggregation
K Number
K213915Device Name
BIB Stent Placement Catheter
Manufacturer
NuMED Inc.
Date Cleared
2022-01-12
(28 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Product Code :
NVM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for CP Stent / Covered CP Stent and G-Armor Covered Stent placement in vessels over 8mm in diameter
Device Description
Not Found
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K Number
K211134Device Name
BIB Stent Placement Catheter
Manufacturer
NuMED, Inc
Date Cleared
2021-05-27
(41 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Product Code :
NVM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
Device Description
Not Found
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K Number
K161451Device Name
BIB Stent Placement Catheter
Manufacturer
NUMED, INC.
Date Cleared
2016-09-22
(119 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Product Code :
NVM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
BIB Stent Placement Catheter
Device Description
Not Found
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K Number
K160889Device Name
BIB Stent Placement Catheter
Manufacturer
NUMED, INC.
Date Cleared
2016-05-20
(50 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Product Code :
NVM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter.
Device Description
The NuMED BIB® Stent Placement Catheter Model 420 is indicated for CP Stent / Covered CP Stent placement in vessels over 8mm in diameter. The catheter is triaxial in construction with two lumens being used to inflate the balloons while one lumen is being used for tracking over a guidewire. The purpose of the double balloon catheter is to apply an incremental inflation for the purpose of dilating a stent. The inner balloon provides initial expansion of the stent and also acts as a tool to hold the stent on the catheter prior to the outer balloon being inflated. The outer balloon is then inflated providing the remainder of the expansion. There are radiopaque platinum marker bands under the balloon shoulders for placement using fluoroscopy. The balloon material is clear. The catheter balloon diameters are stamped onto the inflation extensions and are labeled with balloon diameter x balloon length and the catheter lot number.
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K Number
K050857Device Name
BIB PTA BALLOON CATHETER
Manufacturer
NUMED, INC.
Date Cleared
2005-07-28
(114 days)
Product Code
NVM
Regulation Number
870.1250Why did this record match?
Product Code :
NVM
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This device is labeled for Percutaneous Transluminal Angioplasty (PTA) if the femoral, iliac and renal arteries. These catheters are not designed to be used in the coronary arteries.
Device Description
The BIB PTA Catheter has a tri-axial shaft design which allows for inflation of two balloons, one contained inside the other, and a guidewire lumen for placement inside the vasculature. Both balloons are identical to those currently marketed by NuMed on the Tyshak PTA and Z-Med PTA catheters. The balloons are non-compliant and include radiopaque platinum marker bands on the catheter shaft to facilitate placement of the device under fluoroscopy. The BIB catheter will be available in standard diameters from 8 mm to 24 mm for the outer balloon and 4 mm to 12 mm for the inner balloon. Balloon lengths of 1.5 cm to 5.5 cm will available. The device has an overall shaft length of 110 cm.
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