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510(k) Data Aggregation
K Number
K242154Device Name
Numen Coil Embolization System; NumenFR Detachment System
Manufacturer
MicroPort NeuroTech (Shanghai) Co., Ltd.
Date Cleared
2024-09-30
(69 days)
Product Code
HCG, KRD
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
MicroPort NeuroTech (Shanghai) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels. Numen™ Coil Embolization System is indicated for endovascular embolization of:
- . Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and . arteriovenous fistulae
- . Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
Device Description
The Numen™ Coil Embolization System is composed of two parts as described below:
- An introducer sheath: The function of the introducer sheath is to facilitate introduction . of the coil into the microcatheter.
- . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
The MicroPort NeuroTech NumenFR™ Detachment System is a sterile, handheld, singlepatient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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K Number
K232955Device Name
Numen Coil Embolization System; NumenFR Detachment System
Manufacturer
MicroPort NeuroTech (Shanghai) Co., Ltd.
Date Cleared
2024-01-10
(111 days)
Product Code
HCG, KRD
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
MicroPort NeuroTech (Shanghai) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Numen™ Coil Embolization System is indicated for endovascular embolization of:
-Intracranial aneurysms
-Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae -Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
Device Description
MicroPort NeuroTech has developed the Numen™ Coil Embolization System and NumenFR™ Detachment System. The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use.
The Numen™ Coil Embolization System is composed of two parts as described below:
- . An introducer sheath: The function of the introducer sheath is to facilitate introduction of the coil into the microcatheter.
- . The coil system: The coil system is composed of a pusher and coil implant. The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion.
The MicroPort NeuroTech NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with the MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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K Number
K203625Device Name
Numen Coil Embolization System; NumenFR Detachment System
Manufacturer
MicroPort NeuroTech (Shanghai) Co., Ltd.
Date Cleared
2021-09-01
(264 days)
Product Code
HCG
Regulation Number
882.5950Why did this record match?
Applicant Name (Manufacturer) :
MicroPort NeuroTech (Shanghai) Co., Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Numen™ Coil Embolization System is intended to endovascularly obstruct or occlude blood flow in vascular abnormalities of the neurovascular and peripheral vessels.
Numen™ Coil Embolization System is indicated for endovascular embolization of:
- Intracranial aneurysms
- Other neurovascular abnormalities such as arteriovenous malformations and arteriovenous fistulae
- Arterial and venous embolizations in the peripheral vasculature
NumenFR™ Detachment System is intended for use with MicroPort NeuroTech Numen™ Coil Embolization System in the embolization of intracranial aneurysms and other vascular abnormalities of the neuro and peripheral vasculature.
Device Description
The Numen™ Coil Embolization System is designed to be used in conjunction with the NumenFRTM Detachment System (sold separately) for endovascular embolization of vascular abnormalities described in the intended use. The Numen™ Coil Embolization System is composed of an introducer sheath and the coil system (pusher and coil implant). The coil is a permanent implant intended to occlude blood flow in vascular abnormalities. The pusher is used to deliver the coil implant to the target lesion. The MicroPort NeuroTech NumenFRTM Detachment System is a sterile, handheld, single-patient use device designed for use with MicroPort NeuroTech Numen™ Coil Embolization System. The device is operated by two pre-loaded batteries.
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