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enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wire

Vesalio · Model EV-6035-F2RR-1 · UDI-DI 00850083646028

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1
510(k) clearances
212
Adverse events
0
Recalls
8
Facilities

Description

The enVast Thrombectomy Device is a series of specialized devices with an expandable distal tip which is temporarily inserted into the vasculature to restore blood flow in vessels blocked by an embolus. The expandable tip is a tubular mesh structure laser cut from Nitinol with radiopaque markers in the middle and the proximal and distal ends of the expandable tip. In its expanded shape, the device creates a highly flexible, hybrid closed cell structure. The pusher assembly is composed of an introducer and delivery pusher and is used to deliver the device to the treatment site. The introducer consists of a polymer tube, which protects the device and distal segment of the delivery pusher from damage and creates an uninterrupted passage for the device to be transferred through the microcatheter. The delivery pusher varies in flexibility from the proximal to distal end with the distal section of the delivery is the most flexible and has a radiopaque marker. The pusher controls the deployment of the enVast Device and facilitates advancement and removal of the device through a microcatheter. It is used to track the device to the intended delivery site.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.