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510(k) Data Aggregation
K Number
K023870Device Name
FLEXIMA BILIARY CATHETER
Manufacturer
BOSTON SCIENTIFIC/MEDI-TECH
Date Cleared
2002-12-20
(30 days)
Product Code
FGE
Regulation Number
876.5010Why did this record match?
Applicant Name (Manufacturer) :
BOSTON SCIENTIFIC/MEDI-TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system.
Device Description
The Flexima Biliary Catheter is designed for external and internal percutaneous drainage of the biliary system. The major components of the Flexima Biliary Catheter are the drainage catheter, metal stiffening cannula, flexible stiffening cannula and luer cap.
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K Number
K020012Device Name
MODIFICATION TO RENEGADE FIBER BRAIDED MICROCATHETER
Manufacturer
BOSTON SCIENTIFIC/MEDI-TECH
Date Cleared
2002-01-29
(26 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
BOSTON SCIENTIFIC/MEDI-TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
Device Description
The Renegade™ Fiber Braided Microcatheters are intended for general intravascular use, including neuro, peripheral and coronary vasculature. The catheter can be coaxially tracked over a steerable guidewire in order to access distal, tortuous vasculature. Once the subselective region has been accessed, the catheter can be used for controlled and selective infusion of diagnostic, embolic, or therapeutic materials into vessels.
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K Number
K012948Device Name
MODIFICATION TO VAXCEL DIALYSIS CATHETER
Manufacturer
BOSTON SCIENTIFIC/MEDI-TECH
Date Cleared
2001-10-03
(29 days)
Product Code
MSD
Regulation Number
876.5540Why did this record match?
Applicant Name (Manufacturer) :
BOSTON SCIENTIFIC/MEDI-TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vaxcel™ Dialysis Catheter is designed for chronic hemodialysis and apheresis.
Device Description
The major components of the Vaxcel™ Dialysis Catheter are the dual lumen catheter, hub, injection cap, introducer sheath/dilator and metal tunneler with protective sheath.
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K Number
K012952Device Name
HEMASHIELD GOLD WOVEN DOUBLE VELOUR VASCULAR GRAFT - BRANCH GRAFT
Manufacturer
BOSTON SCIENTIFIC/MEDI-TECH
Date Cleared
2001-10-02
(28 days)
Product Code
DSY
Regulation Number
870.3450Why did this record match?
Applicant Name (Manufacturer) :
BOSTON SCIENTIFIC/MEDI-TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Hemashield Gold ™ Woven Double Velour Vascular Graft is indicated for use in the replacement or repair of arteries affected with aneurysmal or occlusive disease. The prosthesis is also recommended for use in patients requiring systemic heparinization prior to, or during, surgery.
Device Description
The Branch Graft Configurations is different from the rest of the Hemashield Gold Woven Double Velour Vascular Graft product line only in the 1-4 branch configuration in which the grafts are sewn. The modified vascular grafts have the following similarities to those which previously received 510(k) concurrence: Identical indications for use, Identical labeling, Identical manufacturing processes, Identical operating principle, Incorporate identical materials, Have the identical shelf-life (5 years), Are packaged and sterilized using identical packaging materials and processes.
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K Number
K011664Device Name
IMAGER II ANGIOGRAPHIC CATHETER
Manufacturer
BOSTON SCIENTIFIC/MEDI-TECH
Date Cleared
2001-09-07
(100 days)
Product Code
DQO
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
BOSTON SCIENTIFIC/MEDI-TECH
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The IMAGER™II Angiographic Catheters are indicated for use to provide a pathway for delivering contrast media to selected sites in the vascular system.
Device Description
The IMAGER™II Angiographic Catheters are designed to provide a pathway for delivering contrast media to selected sites in the vascular system. The IMAGER™II Angiographic Catheters are sterile, single-use diagnostic intravascular catheters and are available in a variety of flush and selective shapes with lengths of 40 cm, 65 cm, 90cm and 100 cm. The distal segment of the catheter is radiopaque to aid in visualization of the device under fluoroscopy.
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