Home GUDID B090P11090F1 VentiV Scientific
Primary DI B090P11090F1
Brand VentiV Scientific
Company ZIEN MEDICAL TECHNOLOGIES, INC.
Model P11-090-F
Catalog number P11-090-F
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 Code Name QEZ Aspiration Thrombectomy Catheter
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class QEZ Aspiration Thrombectomy Catheter Cardiovascular 2
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B090P11090F1 Package HIBCC 1 In Commercial Distribution B090P11090F2 Package HIBCC 5 In Commercial Distribution B090P11090F0 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Thrombectomy suction catheter A 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.
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# Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 00763000998011 Liberant™ MEDTRONIC, INC. QEZ 2026-05-09 10841156110505 PRONTO TELEFLEX INCORPORATED QEZ 2026-03-30 00851279008910 pVasc Aspiration Catheter 70, 115 cm Vesalio QEZ 2026-03-26 00851279008927 pVasc Aspiration Catheter 70, 125 cm Vesalio QEZ 2026-03-26 00851279008934 pVasc Aspiration Catheter 70, 132 cm Vesalio QEZ 2026-03-26 00851279008941 pVasc Aspiration Catheter 70, 140 cm Vesalio QEZ 2026-03-26 00860011713104 FLOWRUNNER 14F Aspiration System, 80cm Expanse Medical, Inc. QEZ 2026-01-12 00860011713111 FLOWRUNNER 12F Aspiration System, 120cm Expanse Medical, Inc. QEZ 2026-01-12 00860011713128 FLOWRUNNER 12F Aspiration System, 80cm Expanse Medical, Inc. QEZ 2026-01-12 00860011713142 FLOWRUNNER 14F Aspiration System, 120cm Expanse Medical, Inc. QEZ 2026-01-12 00860011713166 FLOWRUNNER 12F Aspiration System, 100cm Expanse Medical, Inc. QEZ 2026-01-12 00860011713180 FLOWRUNNER 14F Aspiration System, 100cm Expanse Medical, Inc. QEZ 2026-01-12 B090P110900 VentiV Scientific ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2025-11-24 B090P11090F0 VentiV Scientific ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2025-11-24 B090P110901 VentiV Scientific ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2025-11-24 10841156110482 PRONTO TELEFLEX INCORPORATED QEZ 2025-09-17 20841156110489 PRONTO TELEFLEX INCORPORATED QEZ 2025-09-17 10841156110475 PRONTO TELEFLEX INCORPORATED QEZ 2025-08-25 20841156110472 PRONTO TELEFLEX INCORPORATED QEZ 2025-08-25 10841156110499 PRONTO TELEFLEX INCORPORATED QEZ 2025-03-18 20841156110496 PRONTO TELEFLEX INCORPORATED QEZ 2025-03-18 15051684025966 AlphaVac Angiodynamics, Inc. QEZ 2024-09-27 15051684025959 AlphaVac Angiodynamics, Inc. QEZ 2024-09-27 15051684025942 AlphaVac Angiodynamics, Inc. QEZ 2024-09-27 00813132029869 QuickClear Aspiration Pump Philips Image Guided Therapy Corporation QEZ 2023-06-09 B090ASP10130 Control 7F Mechanical Thrombectomy System ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2023-05-03 B090ASP10210 Control 11F Mechanical Thrombectomy System ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2023-05-03 B090ASP10330 Control 7F Mechanical Thrombectomy System ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2023-05-03 B090ASP10360 Control 11F Mechanical Thrombectomy System ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2023-05-03 B090ASP10131 Control 7F Mechanical Thrombectomy System ZIEN MEDICAL TECHNOLOGIES, INC. QEZ 2023-05-03