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510(k) Data Aggregation
K Number
K112961Device Name
CLO-SURPLUS P.A.D.
Manufacturer
SCION CARDIO-VASCULAR, INC.
Date Cleared
2011-10-31
(27 days)
Product Code
QSY, FRO, LYA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SCION CARDIO-VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scion Cardio-Vascular Clo-SurPUS P.A.D. is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy.
The dressing is indicated for the following wounds: lacerations, nose bleeds, surgical debridement sites, skin surface puncture sites, vascular sites, and sites involving percutaneous catheters, tubes and pins.
Device Description
The Scion Cardio-Vascular Clo-SurPLUS PADTM is a soft, nonwoven topical pad that provides an optimal wound healing environment, combining an effective antibacterial barrier activity with exudates management.
An optional slit Clo-SurfLUS PAD™ allows for easier placement of the dressing around pins and tubes.
Clo-Sur PLUS PADTM has demonstrated in-vitro antibacterial activity for up to 144 hours (6 days) in certain strains shown to be detrimental to wound healing such as: Escherichia Coli, Staphylococcus Aureus, Streptococcus pyogenes, Pseudomonas aeruginosa, Bacillus cereus, Enterococcus faecium, Candida Albicans and Asperigillus brasiliensis.
Clo-SurPLUS PAD™ is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10°6 SAL.
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K Number
K092552Device Name
CLO-SURPLUS P.A.D.
Manufacturer
SCION CARDIO-VASCULAR, INC.
Date Cleared
2009-09-04
(15 days)
Product Code
QSY, LYA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SCION CARDIO-VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Not Found
Device Description
Not Found
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K Number
K052509Device Name
M-BOLUS EMBOLIC MICROSPHERES
Manufacturer
SCION CARDIO-VASCULAR, INC.
Date Cleared
2006-12-11
(454 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
SCION CARDIO-VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The M-BolusTM Embolic Microspheres are intended for the embolization of arteriovenous malformations (AVMs) and hypervascular tumors. They may be used for vascular occlusion of vessels within the neurovascular system when presurgical devascularization is desirable.
Device Description
M-BOLUSTM Embolic Microspheres are made out of a biocompatible, non-degradable and non-absorbable synthetic polymer called Polyvinyl Alcohol (PVA). The M-BOLUSTM Embolic Microspheres are precisely manufactured spheres, with a smooth and lightly porous surface with hydrophilic characteristics. The M-BOLUSTM Embolic Microspheres, which are supplied in a hydrated state (0.9% Sodium Chloride), are soft and flexible allowing them to be compressed/deformed as they travel through the lumen of a delivery catheter or the vasculature. The Scion Cardio-Vascular M-BOLUSTM Embolic Microspheres are substantially equivalent to the predicate devices.
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K Number
K032986Device Name
CLO-SURPLUSP.A.D.
Manufacturer
SCION CARDIO-VASCULAR, INC.
Date Cleared
2004-03-01
(159 days)
Product Code
QSY, FRO, LYA
Regulation Number
N/AWhy did this record match?
Applicant Name (Manufacturer) :
SCION CARDIO-VASCULAR, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Scion Cardio-Vascular Clo-SurPLUS P.A.D., is intended for the local management of bleeding wounds and to provide a barrier to bacterial penetration of the dressing in all patients and for the promotion of rapid control (hemostasis) of bleeding in patients following hemodialysis and for those on anticoagulation therapy. The dressing is indicated for the following wounds: lacerations, abrasions, nose bleeds, and the skin surface puncture sites for vascular procedures, percutaneous catheters or tubes.
Device Description
The Scion Cardio-Vascular Clo-SurPLUS P.A.D. is a soft, non-woven pad that provides an optimal wound-healing environment, combining an effective antibacterial barrier activity with exudates management. Clo-SurPLUS P.A.D. has demonstrated in-vitro antibacterial activity meant to prevent microbial colonization and penetration of the dressing. Clo-SurPLUS P.A.D. is a sterile topical hemostasis pad, packed in a foil pouch and sterilized by E-beam radiation to a 10-6 SAL.
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