FDA.reportPublic FDA data

NeVa VS - Vessel Dilation Device

Primary DI
00851279008767
Brand
NeVa VS - Vessel Dilation Device
Company
Vesalio
Model
VS-4022-F1RR
Catalog number
VS-4022-F1RR
Device description
Temporary percutaneous transluminal cerebral artery dilation device.
Published
2022-10-27
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QTKTemporary Percutaneous Transluminal Cerebral Artery Dilatation Device

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QTKTemporary Percutaneous Transluminal Cerebral Artery Dilatation DeviceUnknownf

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
H210004000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
H210004000

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00851279008767PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00851279008767008512790087678512790087670851279008767

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA 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 to obtain blood samples. 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

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