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510(k) Data Aggregation
K Number
K213166Device Name
Thrombuster II Aspiration Catheter
Manufacturer
Kaneka Medical America LLC
Date Cleared
2021-10-26
(28 days)
Product Code
QEZ
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Kaneka Medical America LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thrombuster II Aspiration Catheter is indicated for the removal and thrombi from vessels in the coronary and peripheral system. The Thrombuster II is not in the cerebral vasculature.
Device Description
Thrombuster II Aspiration Catheter [Thrombuster II] is a rapid exchange type of dual lumen catheter for embolectomy. The main body consists of a distal shaft, proximal shaft, ring marker, hub, and strain relief. The catheter working length is 1400 mm. This product includes a core wire to resist kink during delivery in clinical usage, syringe kit (extension tube, stopcock, and lock syringe) for connecting the catheter main body and aspiration of fresh, soft emboli and thrombi, and accessories (flushing needle and filter). After insertion of the catheter into a patient body, this product aspirates and removes emboli or thrombi from a target lesion by transmitting negative pressure generated by connected lock syringe to the distal end of the catheter.
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K Number
K210638Device Name
i-ED COIL System
Manufacturer
Kaneka Medical America LLC
Date Cleared
2021-03-26
(23 days)
Product Code
HCG, KRD
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
Kaneka Medical America LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The i-ED COIL System (i-ED COIL and EDG v4) is intended for the endovascular embolization of intracranial aneurysms and other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae. The i-ED COIL System is also intended for vascular occlusion of blood vessels within the neurovascular system to permanently obstruct blood flow to an aneurysm or other vascular malformation and venous embolizations in the peripheral vasculature.
Device Description
i-ED COIL System is a neurovascular and vascular embolization device, which consists of two component devices, i-ED COIL Detachable Coil (hereafter i-ED COIL) and ELECTRO DETACH GENERATOR v4 Detachment System (hereafter EDG v4).
The i-ED COIL is composed of a detach coil and a sheath adapter. Furthermore, the detach coil consists of a platinum coil (embolization material), to be placed at the site of vascular diseases, a pusher (delivery wire) to guide the platinum coil to the site of vascular diseases and a PVA (polyvinyl alcohol) rod that connects the platinum coil and the pusher. The sheath adapter consists of a PP (polypropylene) sheath and an adapter. The i-ED COIL is designed for use with the EDG v4.
The EDG v4 consists of a power source and connection cables attached with clips. EDG v4 is a medical electrical equipment to be used to detach the implantable platinum coil from the delivery wire of the i-ED COIL. It is intended for use in multiple coil detachments performed during a single procedure.
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