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510(k) Data Aggregation
K Number
K094018Device Name
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Manufacturer
BIOCOMPATIBLES U.K. LIMITED
Date Cleared
2010-04-16
(108 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES U.K. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LC Bead Microspheres & Bead Block Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations.
Device Description
LC Bead/Bead Block are preformed, soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). LC Bead/Bead Block consists of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. Bead Block is dyed blue (LC Bead are available as blue and in natural color) to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
LC Bead is supplied sterile and packaged in sealed glass vials. Bead Block is supplied sterile and packaged in polycarbonate syringes. The product configurations are described in the table. LC Bead/Bead Block are supplied in several unit sizes covering the range from 100-1200um diameter. At the time of use, LC Bead/Bead Block is mixed with a nonionic contrast agent, e.g. Omnipaque™, to make a 30-50% by weight solution.
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K Number
K083091Device Name
LC BEAD MICROSPHERES, BEAD BLOCK COMPRESSIBLE MICROSPHERES
Manufacturer
BIOCOMPATIBLES U.K. LIMITED
Date Cleared
2008-12-24
(68 days)
Product Code
KRD, HCG
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES U.K. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LC Bead Microspheres & Bead Block™ Compressible Microspheres is intended for embolization of hypervascular tumors and arteriovenous malformations.
Device Description
LC Bead and Bead Block™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). LC Bead and Bead Block ™ Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. Bead Block™ Compressible Microspheres is dyed blue (LC Bead are available in natural color) to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
LC Bead Microspheres is supplied sterile and packaged in sealed glass vials. Bead Block™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL LC Bead /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL LC Bead/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
LC Bead and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100um to 1200um diameter.
At the time of use, LC Bead/Bead Block™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
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K Number
K042231Device Name
GELSPHERES MICROSPHERES AND BEAD BLOCK COMPRESSIBLE MICROSPHERES
Manufacturer
BIOCOMPATIBLES U.K. LIMITED
Date Cleared
2004-11-12
(87 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES U.K. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GelSpheres™/Bead Block™ Compressible Microspheres are indicated for Embolization of hypervascular tumors and arteriovenous malformations (AVM's).
Device Description
GelSpheres™ and Bead Block™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and Bead Block ™ Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. Bead Block™ Compressible Microspheres is dyed blue (GelSpheres™ are available in natural color) to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
GelSpheres ™ Microspheres is supplied sterile and packaged in sealed glass vials. Bead Block™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /Bead Block™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL, and (2) 2.0mL GelSpheres™/Bead Block™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
GelSpheres™ and Bead Block Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200um diameter. At the time of use, GelSpheres"™/Bead Block™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
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K Number
K033761Device Name
GELSPHERES / BEADBLOCK COMPRESSIBLE MICROSPHERES
Manufacturer
BIOCOMPATIBLES U.K. LIMITED
Date Cleared
2004-02-04
(64 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES U.K. LIMITED
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
GelSpheres™ Compressible Microsphere and BeadBlock™ Compressible Microspheres are intended for embolization of hypervascular tumors and arteriovenous malformations.
Device Description
GelSpheres™ and BeadBlock™ Compressible Microspheres are preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a hypervascular tumor or arteriovenous malformations (AVM's). GelSpheres™ and BeadBlock Compressible Microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90% water and is compressible to approximately 20-30% by diameter. GelSpheres™ and BeadBlock Compressible Microspheres is dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.8-5Fr range.
GelSpheres™ Compressible Microspheres is supplied sterile and packaged in sealed glass vials. BeadBlock ™ Compressible Microspheres is supplied sterile and packaged in a polycarbonate syringe. Two quantities will be available in a vial: (1) 1.0 mL GelSpheres™ /BeadBlock™ Compressible Microspheres in sterile physiologic buffered saline (PBS) to a volume of 8 mL., and (2) 2.0mL GelSpheres™/BeadBlock™ Compressible Microspheres in sterile PBS to a volume of 8 mL.
GelSpheres™ and BeadBlock Compressible Microspheres are supplied in several unit sizes covering the range from 100μm to 1200μm diameter. At the time of use, GelSpheres™/BeadBlock™ Compressible Microspheres is mixed with a nonionic contrast agent, e.g. Omnipaque, to make a 30-50% by weight solution. The bolus of contrast agent elutes from the vascular bed to leave a radiolucent, embolized vessel.
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