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510(k) Data Aggregation
K Number
K210190Device Name
ClotTriever Thrombectomy System
Manufacturer
Irani Medical, Inc.
Date Cleared
2021-02-23
(29 days)
Product Code
QEW
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Irani Medical, Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ClotTriever Thrombectomy System is indicated for :
- · The non-surgical removal of thrombi and emboli from blood vessels.
- · Injection, infusion, and/or aspiration of contrast media and other fluids into or from a blood vessel.
The ClotTriever Thrombectomy System is intended for use in the peripheral vasculature including deep vein thrombosis (DVT).
Device Description
The ClotTriever Thrombectomy System is a single-use, sterile medical device designed for use in the peripheral vasculature. The ClotTriever Thrombectomy System consists of the ClotTriever Sheath and the ClotTriever Catheter. The ClotTriever Sheath comprises a reinforced polymeric sheath equipped with a self-expanding distal mesh funnel, a flush/aspiration port, and a proximal hemostatic valve. A dilator is provided to aid insertion. Other provided accessories include the funnel loading tool and a Large Bore 60 cc syringe. The ClotTriever Catheter comprises reinforced polymeric coaxial shafts terminating in an expandable coring element and thrombus collection bag. Two ports terminating in stopcocks are provided for de-airing the catheter shafts. To aid in fluoroscopic visualization, the Sheath dilator and ClotTriever Catheter distal tips are radiopaque.
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