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510(k) Data Aggregation
K Number
K201652Device Name
COBRA-OS Kit
Manufacturer
Front Line Medical Technologies, Inc.
Date Cleared
2021-02-22
(249 days)
Product Code
MJN
Regulation Number
870.4450Why did this record match?
Applicant Name (Manufacturer) :
Front Line Medical Technologies, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The COBRA-OS™ is intended for temporary occlusion of large vessels including patients requiring emergency control of hemorrhage.
Device Description
The COBRA-OS™ is a large vessel occlusion device and includes a 4 French Custom Sheath Introducer Kit and a 10 cc syringe.
The occlusion device consists of a stiff inner guidewire with an atraumatic floppy distal J-tip that is housed in a compliant occlusion balloon with proximal and distal necks. The inner guidewire provides adequate stiffness. No other guidewires are required. The proximal neck of the balloon is connected to an overmolded hub and stopcock for balloon inflation and deflation. Suture tabs on the overmolded hub are used to secure the device to the patient's skin with sutures. A J-tip straightener is included and preloaded on the distal neck to facilitate the introduction of the device into the 4 French introducer sheath hemostasis valve. Pad printing marks on the outer occlusion device shaft indicate distance to the desired location.
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