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510(k) Data Aggregation
K Number
K032619Device Name
MICROSTAT PVA FOAM EMBOLIZATION PARTICLES
Manufacturer
SURGICA CORP.
Date Cleared
2004-02-13
(171 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
SURGICA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgica Corporation MicroStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
Device Description
Surgica Corporation MicroStat™ Polyvinyl Alcohol (PVA) foam cmbolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyviny) Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
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K Number
K020033Device Name
MAXISTAT PVA FOAM EMBOLIZATION PARTICLES
Manufacturer
SURGICA CORP.
Date Cleared
2002-05-31
(147 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
SURGICA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Surgica Corporation MaxiStat™ PVA Foam Embolization Particles are intended for the following indication: PVA particles may be used for vascular occlusion of blood vessels within the neurovascular systems. They are intended for use in the endovascular management of arteriovenous malformations (AVMs) and neoplastic lesions when presurgical devascularization is desirable.
Device Description
Surgica Corporation MaxiStat™ Polyvinyl Alcohol (PVA) foam embolization particles are artificial embolization devices used to obstruct or reduce the blood flow to hypervascular or neoplastic lesions via superselective catheter delivery. The embolization particles are supplied in various size ranges to enable appropriate size selection for the lesion to be treated. Polyvinyl Alcohol (PVA) foam embolization particles are designed to be delivered under fluoroscopic guidance through compatible infusion catheters. The product is delivered sterilized with radiation, is nonpyrogenic, and is for single use only.
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K Number
K001678Device Name
PVA FOAM EMBOLIZATION PARTICLES
Manufacturer
SURGICA CORP.
Date Cleared
2001-01-25
(238 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
SURGICA CORP.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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