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NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 180 cm wire System

FDA UDI

Class II (US FDA UDI)

by Vesalio, Inc.

Identity

Trade Name
NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 180 cm wire System FDA UDI
Generic Name
Thrombectomy suction catheter FDA UDI
Device Name
The pVasc 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 of the device and distal 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 NeVa Device and facilitates advancement and removal of the device through a microcatheter. It is used to track the device to the intended delivery site. FDA UDI
Model / Reference
VP-4537-F2RR FDA UDI
Description
The pVasc 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 of the device and distal 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 NeVa Device and facilitates advancement and removal of the device through a microcatheter. It is used to track the device to the intended delivery site. FDA UDI

Identifiers

Catalog Number
VP-4537-F2RR FDA UDI
Primary DI / UDI-DI
00851279008439 FDA UDI
510(k) Number
K201085 FDA UDI
FDA Product Code
QEW FDA UDI
KRA FDA UDI
GMDN Term
Thrombectomy suction catheter FDA UDI

Classification

Device Class
Class II FDA UDI
Regulation Number
870.5150 FDA UDI
870.1210 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

Yes

FDA UDI

Single Use

Yes

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

No

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

No

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

Yes

FDA UDI

Manufacturing Date

No

FDA UDI
MRI Safety
MR Unsafe FDA UDI

Category: Thrombectomy suction catheter

NeVa pVasc 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 180 cm wire System by Vesalio, Inc. — Class II — FDA UDI — listed in FDA GUDID

Similar devices

Also classified as Thrombectomy suction catheter.

Cleared under the same submission

K201085 also covers:

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Vesalio, Inc.

Sources (1)

  • FDA UDI 10dd1759-bf5b-4339-89c3-ec0977d909e9 35 fields · synced May 31, 2026