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510(k) Data Aggregation
K Number
K201705Device Name
ReVene Thrombectomy Catheter
Manufacturer
Date Cleared
2020-12-22
(183 days)
Regulation Number
870.5150Why did this record match?
Applicant Name (Manufacturer) :
Vetex Medical, Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The device is indicated for mechanical de-clotting and controlled and selective infusion of physician specified fluids, including thrombolytics, in the peripheral vasculature.
Device Description
The ReVene Thrombectomy Catheter is a rotational venous thrombus extraction system for the treatment of vessels greater than 6mm diameter. The device is designed to be used in a medical catheter laboratory and allows for optional infusion of thrombolytic agents.
The device is compatible with a 10Fr introducer and includes a wire-braided cobalt chromium basket for thrombus disruption. A rotational thrombus-extractor, consisting of a helical coil housed inside a metal tube, is powered by an internal DC motor and batteries. The extractor runs the length of the catheter, and when activated, the coil rotates and is designed to macerate and transport thrombus from the basket to a collection container outside the body.
The main features of device are:
- . The thrombus disruption cage
- . The non-vessel contact thrombus extractor
- . The handle
The ReVene Thrombectomy Catheter is packaged as a single unit and is sterilized using ethylene oxide. The device is provided sterile, non-pyrogenic and is for single-use only.
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