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510(k) Data Aggregation
K Number
K232260Device Name
Thinline Sheath Introducer
Manufacturer
Inneuroco Inc.
Date Cleared
2023-09-27
(58 days)
Product Code
DYB
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
Inneuroco Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thinline Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures.
Device Description
The Thinline Introducer Sheath is a single-lumen, coil-reinforced catheter. The Thinline Introducer Sheath is available in 11cm and 23cm lengths (French size 9F) and is designed to accept 0.038 inch diameter quide wires. A radiopaque outer laver is included for angiographic visualization. A valved hub with integrated suture ring is attached to the proximal end with extension tubing and a three way stop cock which allows attachments for flushing and aspiration. This catheter is designed for use in providing access and facilitating the percutaneous introduction of various devices into veins and/or arteries while maintaining hemostasis for a variety of diagnostic and therapeutic procedures. The dimensions for the Thinline Introducer Sheath are indicated on the product label. A dilator and guidewire accessory are included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
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K Number
K220331Device Name
091 Balloon Guide Catheter
Manufacturer
InNeuroCo Inc.
Date Cleared
2022-07-29
(175 days)
Product Code
DQY, QJP
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The 091 Balloon Guide Catheter is indicated for use in facilitating the insertion and guidance of intravascular catheters into a selected blood vessel in the peripheral and neuro vascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Device Description
The 091 Balloon Guide Catheter is a coaxial-lumen, coil-reinforced, variable stiffness catheter with a compliant balloon at the distal end to provide temporary vascular occlusion during angiographic procedures. A radiopaque marker is included at the distal end of the distal tip of the catheter) for fluoroscopic visualization. A bifurcated luer hub on the proximal end of the catheter allows attachments for flushing, and aspiration. This catheter is designed for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neuro vascular systems. The dimensions and maximum recommended balloon inflation volume for the 091 Balloon Guide Catheter are indicated on the product label. A Peel-Away Introducer accessory is included within the packaging. It is supplied sterile, non-pyrogenic, and is intended for single use only.
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K Number
K181354Device Name
074 Zenith Flex System
Manufacturer
InNeuroCo Inc.
Date Cleared
2018-10-25
(156 days)
Product Code
NRY
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
InNeuroCo Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Zenith Flex System, including the Zetheter, Aspiration Tubing Set, and VC-701 Cliq Aspirator Pump, is indicated in the revascularization of patients with acute secondary to intracranial large vessel occlusive disease (within the internal carotid, middle cerebral – M1 and M2 segments, basilar, and vertebral arteries) within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who failed IV t-PA therapy are candidates for treatment.
Device Description
The InNeuroCo 074 Zenith Flex Catheter is a variable stiffness catheter that has a catheter shaft reinforced with Stainless-Steel and Nitinol to provide support. The Stainless-Steel is wound as a double coil in the proximal section and the Nitinol is a single coil in the distal section. It has a radiopaque Platinum/lridium marker band on the distal 25 cm of the 074 Zenith Flex Catheter has a hydrophilic coating. The 074 Zenith Flex Catheter is available with an internal diameter of 0.074 inches. The outer diameter is of 0.089 inches along its proximal shaft, and 0.083 inches along its distal shaft. The 074 Zenith Flex Catheter is available in three workinq lengths: 115 cm, 125 cm, and 132 cm. The 074 Zenith Flex Catheter has a PTFE lined lumen. Accessories included with the device are a Tuohy-Borst Hemostasis Valve, two peel-away Introducers, and a Scout introducer. The Scout may be used to introduce the 074 Zenith Flex Catheter into distal vasculature, thereby helping the device reach the target anatomy.
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