FDA.reportPublic FDA data

VentiV Scientific

Primary DI
B090P110901
Brand
VentiV Scientific
Company
ZIEN MEDICAL TECHNOLOGIES, INC.
Model
P11-090
Catalog number
P11-090
Device description
The V-PULSE Mechanical Thrombectomy System is a single-use, over-the-wire ("OTW") intravascular mechanical thrombectomy and extraction device.
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
QEZAspiration Thrombectomy Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEZAspiration Thrombectomy CatheterCardiovascular2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B090P110901PackageHIBCC1In Commercial Distribution
B090P110902PackageHIBCC5In Commercial Distribution
B090P110900PrimaryHIBCC0

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
017535668
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
B090C140900XO Cross 14C14-090C14-0902022-06-20
B090C14090H0XO Cross 14C14-090-HC14-090-H2022-06-21
B090C141350XO Cross 14C14-135C14-1352022-06-20
B090C14135H0XO Cross 14C14-135-HC14-135-H2022-06-20
B090C141750XO Cross 14C14-175C14-1752022-06-20
B090C14175H0XO Cross 14C14-175-HC14-175-H2022-06-21
B090C35090H0XO Cross 35C35-090-HC35-090-H2022-10-24
B090C351350XO Cross 35C35-135C35-1352022-06-20
B090C35135H0XO Cross 35C35-135-HC35-135-H2022-10-24
B090C35175H0XO Cross 35C35-175-HC35-175-H2022-10-24
00853989006002XableCathXC-014-065AXC-014-065A2018-09-24
00853989006019XableCathXC-014-090AXC-014-090A2018-09-24
00853989006026XableCathXC-014-145AXC-014-145A2018-09-24
00853989006033XableCathXC-018-065AXC-018-065A2018-09-24
00853989006040XableCathXC-018-090AXC-018-090A2018-09-24
00853989006057XableCathXC-018-145AXC-018-145A2018-09-24
00853989006064XableCathXC-035-065AXC-035-065A2018-09-24
00853989006071XableCathXC-035-090AXC-035-090A2018-09-24
00853989006088XableCathXC-035-145AXC-035-145A2018-09-24
00853989006095XableCathXC-014-065BXC-014-065B2018-09-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860011713135FLOWRUNNER 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00860011713159FLOWRUNNER SP 7F Aspiration System, 130cmExpanse Medical, Inc.QEZ2026-05-28
00763000998011Liberant™MEDTRONIC, INC.QEZ2026-05-09
10841156110505PRONTOTELEFLEX INCORPORATEDQEZ2026-03-30
00851279008910pVasc Aspiration Catheter 70, 115 cmVesalioQEZ2026-03-26
00851279008927pVasc Aspiration Catheter 70, 125 cmVesalioQEZ2026-03-26
00851279008934pVasc Aspiration Catheter 70, 132 cmVesalioQEZ2026-03-26
00851279008941pVasc Aspiration Catheter 70, 140 cmVesalioQEZ2026-03-26
00860011713104FLOWRUNNER 14F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713111FLOWRUNNER 12F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713128FLOWRUNNER 12F Aspiration System, 80cmExpanse Medical, Inc.QEZ2026-01-12
00860011713142FLOWRUNNER 14F Aspiration System, 120cmExpanse Medical, Inc.QEZ2026-01-12
00860011713166FLOWRUNNER 12F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
00860011713180FLOWRUNNER 14F Aspiration System, 100cmExpanse Medical, Inc.QEZ2026-01-12
B090P110900VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F0VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
B090P11090F1VentiV ScientificZIEN MEDICAL TECHNOLOGIES, INC.QEZ2025-11-24
10841156110482PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
20841156110489PRONTOTELEFLEX INCORPORATEDQEZ2025-09-17
10841156110475PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
20841156110472PRONTOTELEFLEX INCORPORATEDQEZ2025-08-25
10841156110499PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
20841156110496PRONTOTELEFLEX INCORPORATEDQEZ2025-03-18
15051684025966AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025959AlphaVacAngiodynamics, Inc.QEZ2024-09-27
15051684025942AlphaVacAngiodynamics, Inc.QEZ2024-09-27
00813132029869QuickClear Aspiration PumpPhilips Image Guided Therapy CorporationQEZ2023-06-09
B090ASP10130Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10210Control 11F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03
B090ASP10330Control 7F Mechanical Thrombectomy SystemZIEN MEDICAL TECHNOLOGIES, INC.QEZ2023-05-03