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510(k) Data Aggregation
K Number
K233924Device Name
EMBOGUARD Balloon Guide Catheter
Manufacturer
Date Cleared
2024-04-18
(127 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Neuravi Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
Device Description
EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.
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K Number
K212340Device Name
EMBOGUARD Balloon Guide Catheter
Manufacturer
Date Cleared
2021-12-17
(142 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Neuravi Limited
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
EMBOGUARD Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravasular catheter into a selected blood vessel in the neurovascular system. The balloon provides temporary vascular occlusion during angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval Devices.
Device Description
EMBOGUARD Balloon Guide Catheter is a dual lumen, braid-reinforced, variable stiffness catheter with an eccentric inflation lumen, a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A compliant balloon is mounted on the distal end. The distal end of the device shaft has a hydrophilic coating. Balloon Guide Catheter dimensions are indicated on the product label.
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Ask a specific question about this device
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