FDA.report

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

Primary DI
00850083646028
Brand
enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wire
Company
Vesalio
Model
EV-6035-F2RR-1
Catalog number
EV-6035-F2RR-1
Device 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.
Published
2026-03-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QEXCoronary Mechanical Thrombectomy With Aspiration

Product Code Classifications

CodeDeviceSpecialtyClass
QEXCoronary Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions

SubmissionSupplement
K253407000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K253407000NeVa PV Thrombectomy DeviceVesalio, Inc.2025-11-24QEX

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00850083646028PrimaryGS10

GMDN Terms

TermDefinition
Thrombectomy wire-netA device intended to be percutaneously introduced into the vasculature (coronary, peripheral and/or intracranial) through an appropriate intravascular catheter for the removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction; revascularization may also be achieved through thrombus reorientation. Also referred to as a stent retriever or clot retrieval catheter, it consists of an expanding, stent-like wire net connected to a pusher wire primarily intended to grip and remove the emboli/thrombi; it might include a guide-catheter dedicated to introduction of the wire-net. This is a single-use device.

Sterilization Methods

Method

Regulatory Flags

DUNS number
080986009
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireEV-4537-F2RR-1EV-4537-F2RR-12026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireEV-4546-F3RR-1EV-4546-F3RR-12026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireEV-4030-F2RR-1EV-4030-F2RR-12026-03-20
00851279008378NeVa pVasc 4.0 x 22 mm - 2 Drop Zones - 180 cm wire SystemVP-4022-02RRVP-4022-02RR2024-04-03
00851279008385NeVa pVasc 4.0 x 22 mm - 2 Drop Zones - 300 cm wire SystemVP-4022-02RXVP-4022-02RX2024-04-03
00851279008392NeVa pVasc 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 180 cm wire SystemVP-4030-F2RRVP-4030-F2RR2024-04-03
00851279008408NeVa pVasc 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 300 cm wire SystemVP-4030-F2RXVP-4030-F2RX2024-04-03
00851279008415NeVa pVasc 4.0 x 38 mm - Flow Restoration, 3 Drop Zones - 180 cm wire SystemVP-4038-F3RRVP-4038-F3RR2024-04-03
00851279008422NeVa pVasc 4.0 x 38 mm - Flow Restoration, 3 Drop Zones - 300 cm wire SystemVP-4038-F3RXVP-4038-F3RX2024-04-03
00851279008439NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 180 cm wire SystemVP-4537-F2RRVP-4537-F2RR2024-04-03
00851279008446NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 300 cm wire SystemVP-4537-F2RXVP-4537-F2RX2024-04-03
00851279008453NeVa pVasc 4.5 x 29 mm - 3 Drop Zones - 180 cm wire SystemVP-4529-03RRVP-4529-03RR2024-04-03
00851279008460NeVa pVasc 4.5 x 29 mm - 3 Drop Zones - 300 cm wire SystemVP-4529-03RXVP-4529-03RX2024-04-03
00851279008477NeVa pVasc 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 180 cm wire SystemVP-4546-F3RRVP-4546-F3RR2024-04-03
00851279008484NeVa pVasc 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 300 cm wire SystemVP-4546-F3RXVP-4546-F3RX2024-04-03
00851279008491NeVa pVasc 4.5 x 44 mm - 5 Drop Zones - 180 cm wire SystemVP-4544-05RRVP-4544-05RR2024-04-03
00851279008507NeVa pVasc 6.0 x 35 mm - Flow Restoration, 2 Drop Zones -180 cm wire SystemVP-6035-F2RRVP-6035-F2RR2024-04-03
00851279008514NeVa pVasc 6.0 x 44 mm - Flow Restoration, 3 Drop Zones - 180 cm wire SystemVP-6044-F3RRVP-6044-F3RR2024-04-03
00851279008767NeVa VS - Vessel Dilation Device30050V-VSVS-4022-F1RR2022-10-27

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEX2026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEX2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEX2026-03-20