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510(k) Data Aggregation
K Number
DEN230064Device Name
BraidE Embolization Assist Device
Manufacturer
Date Cleared
2024-02-21
(155 days)
Product Code
Regulation Number
870.3325Why did this record match?
Applicant Name (Manufacturer) :
Rapid Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BraidE Embolization Assist Device is indicated for use in the peripheral vasculature as a temporary endovascular device used to assist in the coil embolization of wide-necked peripheral aneurysms with a neck width ≤ 10 mm. A wide-necked peripheral aneurysm defines the neck width as > 4 mm or a dome-to-neck ratio < 2.
Device Description
The BraidE Embolization Assist Device is a sterile single use endovascular device intended to provide temporary assistance for the coil embolization of wide-necked peripheral aneurysms. The BraidE is comprised of a nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The braided mesh at the distal portion of the device is shown in Figure 2. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider. Because the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the aneurysm neck morphology and vessel requirement.
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K Number
K230429Device Name
Tigertriever 21 Revascularization Device, Tigertriever 17 Revascularization Device, Tigertriever 13 Revascularization Device
Manufacturer
Date Cleared
2023-04-17
(59 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Rapid Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.
Device Description
The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neurointerventional procedures and the treatment of ischemic stroke.
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K Number
K220808Device Name
Tigertriever 13 Revascularization Device
Manufacturer
Date Cleared
2022-07-25
(129 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Rapid Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.
Device Description
The Tigertriever 13 device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. The Tigertriever 13 Revascularization Device is supplied sterile and is intended for single-use only by physicians trained in neuro-interventional catheterization and the treatment of ischemic stroke.
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K Number
K203592Device Name
Tigertriever and Tigertriever 17 Revascularization Devce
Manufacturer
Date Cleared
2021-03-23
(105 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
Rapid Medical Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Tigertriever Revascularization Device is intended to restore blood flow by removing thrombus from a large intracranial vessel in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA), or who fail IV t-PA therapy, are candidates for treatment.
Device Description
The Tigertriever device is a stentriever that is comprised of an adjustable nitinol braided mesh, stainless steel shaft, nitinol core wire and a handle. The shaft connects the mesh and the handle by the core wire that runs inside the shaft from the distal end of the mesh to the slider activation element in the handle. The mesh is expanded when the physician pulls the slider, since the wires of the mesh are completely radiopaque, the physician sees the mesh under fluoroscopy and controls it until it conforms to the vessel diameter. The design of the wire mesh is optimized to penetrate the clot and encapsulate it during retrieval. Two versions of the device are available. The standard version Tigertriever (TRPP7155) has a net length of 32mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.021 inches. The shorter version Tigertriever 17 (TRPP7166) has a net length of 23 mm (unexpanded form) and it is delivered through a microcatheter with an internal diameter of 0.017 inches. The Tigertriever is provided with a 3.5 Fr peelable loading sheath.
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