NeVa VS - Vessel Dilation Device VS-4022-F1RR

GUDID 00851279008767

Temporary percutaneous transluminal cerebral artery dilation device.

Vesalio

Thrombectomy suction catheter

• Primary Device ID: 00851279008767
• NIH Device Record Key: acb1b6cb-93fb-4427-8ff3-f2a11b7814ea
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: NeVa VS - Vessel Dilation Device
• Version Model Number: 30050V-VS
• Catalog Number: VS-4022-F1RR
• 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: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00851279008767 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• H210004

FDA Product Code

• QTK: Temporary Percutaneous Transluminal Cerebral Artery Dilatation Device

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: 2022-11-04
• Device Publish Date: 2022-10-27

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: 2026-03-30 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