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510(k) Data Aggregation
K Number
K021210Device Name
ARTERIA OCCLUSION BALLOON
Manufacturer
ARTERIA MEDICAL SCIENCE, INC.
Date Cleared
2002-10-28
(194 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
ARTERIA MEDICAL SCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ArteriA Occlusion Balloon is indicated for use as an intravascular occluding catheter with an inflatable balloon tip that is used for temporary occlusion of vessels. The technique of temporary occlusion is useful in selectively stopping or controlling blood flow. The ArteriA Occlusion Balloon may be used in the peripheral and neuro-vasculature where temporary occlusion is desired during endovascular procedures.
Device Description
The ArteriA Occlusion Balloon is a single lumen, intravascular catheter with a compliant balloon at the distal end. An adapter at the proximal end of the shaft accesses the lumen. The catheter is constructed of stainless steel and a composite device designed to access the vessel. The proximal end of the catheter is fitted with an adapter. This adapter connects to the balloon inflation lumen and a fitting for attachment of a standard inflation syringe. The ArteriA Occlusion Catheter is supplied sterile and for single use.
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K Number
K021293Device Name
ARTERIA BLOOD FILTER
Manufacturer
ARTERIA MEDICAL SCIENCE, INC.
Date Cleared
2002-08-22
(121 days)
Product Code
FPB
Regulation Number
880.5440Why did this record match?
Applicant Name (Manufacturer) :
ARTERIA MEDICAL SCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ArteriA Blood Filter is intended for use as an accessory in the administration of blood, blood components or solutions into a patient's vascular system through a venous access device.
Device Description
The ArteriA Blood Filter device is a blood transfusion filter and drip chamber connected to flexible medical grade tubing having a connector on each end. The input side to the dripchamber/filter has a three-way stopcock valve that has both a male and female Luer connections available for use. The outlet of the drip-chamber/filter has a male Luer connector that facilitates connection to a venous access device such as a catheter or sheath. It may also be connected to another stopcock.
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K Number
K001917Device Name
PARODI CATHETER FOR ANGIOGRAPHY (PARCA)
Manufacturer
ARTERIA MEDICAL SCIENCE, INC.
Date Cleared
2001-06-06
(348 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
ARTERIA MEDICAL SCIENCE, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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