FDA.reportPublic FDA data

NeVa pVasc 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 300 cm wire System

Primary DI
00851279008484
Brand
NeVa pVasc 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 300 cm wire System
Company
Vesalio
Model
VP-4546-F3RX
Catalog number
VP-4546-F3RX
Device description
The NeVa 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 pVasc 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
2024-04-03
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K201085000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K201085000NeVa PV Thrombectomy DeviceVesalio2021-01-15QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851279008484PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851279008484008512790084848512790084840851279008484

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Sterilization Methods#

Method table
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
false
Sterilization required before use
false

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
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
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083646028enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-03-13
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
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00860008103819Recana Debulking CatheterIntervene, Inc.QEW2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.QEW2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.QEW2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.QEW2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
M917RVHD0RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXInari Medical, Inc.QEW2026-01-06
00810123710256Artix AXInari Medical, Inc.QEW2026-01-06
00810169722480Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
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00810169722527Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722534Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722541Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
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00763000849801Liberant™MEDTRONIC, INC.QEW2025-11-16