enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire EV-4537-F2RR-1

GUDID 00850083646042

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.

Vesalio

Thrombectomy wire-net

• Primary Device ID: 00850083646042
• NIH Device Record Key: cb78edfe-6d8e-41d2-bafa-b472aaf322d8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire
• Version Model Number: EV-4537-F2RR-1
• Catalog Number: EV-4537-F2RR-1
• Company DUNS: 080986009
• Company Name: Vesalio
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Unsafe
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: true
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850083646042 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K253407

FDA Product Code

• QEX: Coronary Mechanical Thrombectomy With Aspiration

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2026-03-30
• Device Publish Date: 2026-03-20

Devices Manufactured by Vesalio

• 00850083646028 - enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wire: 2026-03-30 The enVast Thrombectomy Device is a series of specialized devices with an expandable distal tip which is temporarily inserted in
• 00850083646042 - enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire: 2026-03-30The 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.
• 00850083646042 - enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wire: 2026-03-30 The enVast Thrombectomy Device is a series of specialized devices with an expandable distal tip which is temporarily inserted in
• 00850083646059 - enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wire: 2026-03-30 The enVast Thrombectomy Device is a series of specialized devices with an expandable distal tip which is temporarily inserted in
• 00850083646066 - enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wire: 2026-03-30 The enVast Thrombectomy Device is a series of specialized devices with an expandable distal tip which is temporarily inserted in
• 00851279008378 - NeVa pVasc 4.0 x 22 mm - 2 Drop Zones - 180 cm wire System: 2024-04-11 The NeVa pVasc Device is a series of specialized devices with an expandable distal tip which is temporarily inserted into the va
• 00851279008385 - NeVa pVasc 4.0 x 22 mm - 2 Drop Zones - 300 cm wire System: 2024-04-11 The NeVa PV Device is a series of specialized devices with an expandable distal tip which is temporarily inserted into the vascu
• 00851279008392 - NeVa pVasc 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 180 cm wire System: 2024-04-11 The NeVa pVasc Device is a series of specialized devices with an expandable distal tip which is temporarily inserted into the va
• 00851279008408 - NeVa pVasc 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 300 cm wire System: 2024-04-11 The NeVa pVasc Device is a series of specialized devices with an expandable distal tip which is temporarily inserted into the va