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510(k) Data Aggregation
K Number
K233420Device Name
Axium Detachable Coil; Axium Prime Detachable Coil
Manufacturer
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
Date Cleared
2023-11-07
(28 days)
Product Code
HCG, KRD
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Axium™ Detachable Coil:
Axium™ Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. Axium™ Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil:
(Models: APB-X-Y-3D-ES, APB-X-Y-3D-SS, APB-X-Y-HX-ES, APB-X-Y-HX-SS)
The Axium™ Prime Detachable Coils are intended for the endovascular embolization of intracranial aneurysms. The Axium™ Prime Detachable Coils are also intended for the embolization of other neuro vascular abnormalities such as arteriovenous malformations and arteriovenous fistulae.
Axium™ Prime Detachable Coil:
(Models: FC-X-Y-3D)
The Axium™ Prime Detachable Col is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities, such as arteriovenous malformations and arteriovenous fistulae. The Axium™ Prime Detachable Coils are also intended for arterial and venous embolizations in the peripheral vasculature.
Device Description
The Axium™ Detachable Coil and Axium™ Prime Detachable Coil consist of a platinum embolization coil attached to a composite implant delivery pusher with a radiopaque positioning marker and a hand-held Instant Detacher (I.D.) which when activated detaches the coil from the delivery pusher tip. The I.D. is sold separately.
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K Number
K210230Device Name
Phenom Catheters
Manufacturer
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
Date Cleared
2021-02-25
(28 days)
Product Code
DQY, KRA, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Micro Therapeutics, lnc. d/b/a ev3 Neurovascular
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Phenom™ Catheters are intended for the introduction of interventional devices or diagnostic agents into the neuro, peripheral, and coronary vasculatures.
Device Description
The Phenom™ Catheters are variable stiffness, single lumen catheters designed to access small, tortuous vasculature. They are available in a variety of lengths, stiffness and inner and outer diameters. The outer surface of the catheter is coated to enhance navigation in the vessel. The Phenom™ 17, 21, and 27 Catheters have a hydrophilic coating that spans the distal 100cm. The Phenom™ Plus Catheters have a hydrophilic coating that spans the distal 90cm. The catheter also incorporates a liner to facilitate movement of introduction devices passing through its lumen. The distal tip has radiopaque marker(s) to aid visualization and positioning under fluoroscopy. The Phenom™ Catheter is packaged with a shaping mandrel and may be accompanied with a split introducer sheath.
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