enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire

Primary DI
00850083646042
Brand
enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire
Company
Vesalio
Model
EV-4537-F2RR-1
Catalog number
EV-4537-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
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration
QEXCoronary Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2
QEXCoronary Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K253407000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K253407000NeVa PV Thrombectomy DeviceVesalio, Inc.2025-11-24QEX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850083646042PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850083646042008500836460428500836460420850083646042

GMDN Terms#

Term, Definition table
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 table
Method

Regulatory Flags#

DUNS number
080986009
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850083646004NeVasc .070 Aspiration Catheter, 115 cmVC-070-115VC-070-1152026-03-26
00851279008910pVasc Aspiration Catheter 70, 115 cmVP-AC-070-115VP-AC-070-1152026-03-26
00851279008927pVasc Aspiration Catheter 70, 125 cmVP-AC-070-125VP-AC-070-1252026-03-26
00851279008934pVasc Aspiration Catheter 70, 132 cmVP-AC-070-132VP-AC-070-1322026-03-26
00851279008941pVasc Aspiration Catheter 70, 140 cmVP-AC-070-1402026-03-26
00851279008972NeVasc .070 Aspiration Catheter, 140 cmVC-070-140VC-070-1402026-03-26
00851279008989NeVasc .070 Aspiration Catheter, 132 cmVC-070-132VC-070-1322026-03-26
00851279008996NeVasc .070 Aspiration Catheter, 125 cmVC-070-125VC-070-1252026-03-26
00850083646028enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wireEV-6035-F2RR-1EV-6035-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
00851279008392NeVa pVasc 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 180 cm wire SystemVP-4030-F2RRVP-4030-F2RR2024-04-03
00851279008439NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 180 cm wire SystemVP-4537-F2RRVP-4537-F2RR2024-04-03
00851279008477NeVa pVasc 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 180 cm wire SystemVP-4546-F3RRVP-4546-F3RR2024-04-03
00851279008514NeVa pVasc 6.0 x 44 mm - Flow Restoration, 3 Drop Zones - 180 cm wire SystemVP-6044-F3RRVP-6044-F3RR2024-04-03
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
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

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