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Found 3 results
510(k) Data Aggregation
K Number
K203276Device Name
Bead Block (100 - 300µm, 1ml), Bead Block (300 - 500µm, 1ml), Bead Block (500 - 700µm, 1ml), Bead Block (700 - 900µm, 1ml), Bead Block (900 - 1200µm, 1ml), Bead Block (100 - 300µm, 2ml), Bead Block (300 - 500µm, 2ml), Bead Block (500 - 700µm, 2ml), Bead Block (700 - 900µm, 2ml), Bead Block (900 - 1200µm, 2ml)
Manufacturer
Biocompatibles UK Ltd (part of Boston Scientific Corporation
Date Cleared
2021-04-20
(165 days)
Product Code
NOY, HCG, KRD, NAJ
Regulation Number
876.5550Why did this record match?
Applicant Name (Manufacturer) :
Biocompatibles UK Ltd (part of Boston Scientific Corporation
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bead Block microspheres are intended to be used for the embolization of hypervascular tumours, including uterine fibroids (UFE) and arteriovenous malformations (AVMs). Bead Block microspheres are also intended for embolization of prostatic arteries (PAE) for symptomatic benign prostatic hyperplasia (BPH).
Device Description
Bead Block, a permanent intravascular implant, is made up of preformed soft, compressible, biocompatible, hydrophilic, non-resorbable and precisely calibrated microspheres that occlude vessels for the purpose of blocking the blood flow to a target tissue. Bead Block compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be suspended in contrast agents and delivered through microcatheters to the target location. Bead Block is available in bead sizes from 100 – 1200µm and supplied sterile in 20ml syringes which contain 1 or 2 ml of beads suspended in 6 or 5 ml of phosphate buffered saline, respectively. The different bead sizes of the product are differentiated by differently colored labels and syringe end caps. Bead Block is provided as a single use, non-pyrogenic, sterile (steam sterilized) device.
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K Number
K150876Device Name
Bead Block
Manufacturer
BIOCOMPATIBLES UK LTD
Date Cleared
2016-03-07
(341 days)
Product Code
KRD, HCG, NAJ
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES UK LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Bead Block™ microspheres are intended to be used for the embolization of hypervascular tumors, including uterine fibroids and arteriovenous malformations (AVMs).
Device Description
Bead Block™ is made up of preformed soft, deformable microspheres that occlude arteries for the purpose of blocking the blood flow to a target tissue, such as a fibroid or a cancerous tumor. Bead Block™ compressible microspheres consist of a macromer derived from polyvinyl alcohol (PVA). The fully polymerized microsphere is approximately 90-95% water and is compressible to approximately 30% by diameter. Bead Block™ microspheres are dyed blue to aid in the visualization of the microspheres in the delivery syringe. The microspheres can be delivered through typical microcatheters in the 1.5-5Fr range.
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K Number
K152157Device Name
LC Bead LUMI
Manufacturer
BIOCOMPATIBLES UK LTD
Date Cleared
2015-12-11
(130 days)
Product Code
KRD
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
BIOCOMPATIBLES UK LTD
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
LC Bead LUMI are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVMs).
Device Description
LC Bead LUMI™ is an imageable spherical embolic product that can be visualised by X-ray based imaging (e.g. fluoroscopy and CT). The beads are non-resorbable microspheres with calibrated size ranges. LC Bead LUMI™ are intended to be used for the embolization of hypervascular tumors and arteriovenous malformations (AVM).
LC Bead LUMI™ are supplied in a saline buffer solution within a sealed glass vial. A vial access device is also provided within the secondary packaging. LC Bead LUMI™ is provided sterile (moist heat sterilization).
LC Bead LUMI™ consist of a macromer derived from a sulphonate modified polyvinyl alcohol (PVA) macromer which contains a radiopaque moiety that is covalently bound within the hydrogel structure. The incorporation of this radiopaque moiety into the co-polymer imparts Xray imageability by rendering the microspheres radiopaque.
LC Bead LUMI™ has been designed as a radiopaque version of the LC Bead™. Currently embolization with LC Bead™ lacks post-procedural imaging feedback on exact bead location. The embolization process with LC Bead™ is monitored by detecting changes in antegrade flow of soluble iodinated contrast in which the beads are diluted. The embolization is continued until a desired embolization endpoint is reached. This process is completed without specific feedback on the bead location. In order to address this limitation, the manufacturer has developed an imageable spherical embolic bead that can be visualised by X-ray based imaging.
At the time of use, LC Bead LUMI™ is mixed with non-ionic contrast agent in order to monitor the delivery of the product during the embolization procedure. LC Bead LUMI™ is delivered via typical microcatheters to physically block the target vessel. Once the product has been delivered the iodine moiety allows for visualization of the microspheres. LC Bead LUMI™ is a single use, tissue contacting, implantable device available only for prescription use.
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