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510(k) Data Aggregation
K Number
K212057Device Name
Endoluminal Occlusion System, EOS-X, Endoluminal Occlusion System, EOS
Manufacturer
Date Cleared
2022-03-01
(243 days)
Product Code
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
ArtVentive Medical Group, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ArtVentive Endoluminal Occlusion System - EOS-X is indicated for arterial and venous embolization in the peripheral vasculature.
Device Description
The ArtVentive Endoluminal Occlusion System (EOS-X) has been developed for arterial and venous embolization in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The EOS-X is intended for single use only.
Like the predicate ArtVentive Endoluminal Occlusion System (EOS)™, the ArtVentive Endoluminal Occlusion System (EOS-X) is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and the catheter's distal end are visible under fluoroscopy.
The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.
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K Number
K150402Device Name
Endoluminal Occlusion System-EOS
Manufacturer
Date Cleared
2015-09-25
(219 days)
Product Code
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
ARTVENTIVE MEDICAL GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ArtVentive Endoluminal Occlusion System (EOS) is intended for arterial and venous embolization in the peripheral vasculature.
Device Description
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the delivery catheter, and the guide catheter with dilator. The AVMG EOS™ is intended for single use only.
Like the parent ArtVentive Endoluminal Occlusion System - EOS, the proposed 11mm size of the device is comprised of an implant made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of a delivery catheter and the guide catheter with dilator. The implant delivery catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability. The implant itself and the catheter's distal end are visible under fluoroscopy.
The guide catheter is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the distal end of the catheter is visible under fluoroscopy. The tip of the guide catheter is tapered to fit over the dilator. The dilator fits inside the guide catheter exiting out through the distal end. The dilator also has a tapered end for ease of advancement into the blood vessel. The guidewire and dilator are removed from the guide catheter once it is in position for delivery of the implant.
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K Number
K133924Device Name
ENDOLUMINAL OCCLUSION SYSTEM (EOS)
Manufacturer
Date Cleared
2014-12-03
(345 days)
Product Code
Regulation Number
870.3300Why did this record match?
Applicant Name (Manufacturer) :
ARTVENTIVE MEDICAL GROUP, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The ArtVentive Medical Group Endoluminal Occlusion System (AVMG EOS) is indicated for the percutaneous occlusion of the peripheral arterial and venous vasculature.
Device Description
The ArtVentive Medical Group Endoluminal Occlusion System™ (AVMG EOS™) has been developed for arterial and venous embolizations in the peripheral vasculature. The system consists of three major components: a preloaded implant, the implant carrier catheter, and the guide sheath with removable core. The AVMG EOS™ is intended for single use only.
The implant is made of a Nitinol coil scaffold with an ePTFE occlusion membrane and is designed with radial force sufficient to provide stiffness and strength against the vessel wall and minimize post-deployment migration. The delivery system is made up of the implant carrier catheter and the guide sheath with removable core. The implant carrier catheter contains one implant loaded on the distal end and a deployment handle on the proximal end connected by the shaft. The delivery catheter has a low profile and is flexible to allow for trackability and pushability. The implant itself and catheter's distal end are visible under fluoroscopy.
The guide sheath is a braided shaft with a stiff proximal section and a more flexible distal section to enable tracking through tortuous peripheral vasculature. A radiopaque marker on the sheath is visible under fluoroscopy. The tip of the sheath is tapered to fit over the removable core. The removable core fits inside the guide sheath, exiting out through the distal end. The removable core also has a tapered end for ease of advancement into the blood vessel. The guidewire and core are removed from the guide sheath once it is in position for delivery of the implant.
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