FDA.reportPublic FDA data

Aventus Thrombectomy System - Aspiration Catheter

Primary DI
00860009303409
Brand
Aventus Thrombectomy System - Aspiration Catheter
Company
Inquis Medical, Inc.
Model
IM-2001
Catalog number
AV24-95-M
Device description
The Aventus Aspiration Catheter is a multi-lumen catheter with a flexible shaft and a tapered radiopaque tip designed to remove thrombus and emboli from the peripheral and/or pulmonary vasculature using manual aspiration.
Published
2024-07-23
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K240117000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K240117000Aventus Thrombectomy System (IM-2001/IM-0002)Inquis Medical2024-03-15QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860009303409PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860009303409008600093034098600093034090860009303409

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
Ethylene Oxide

Contacts#

Phone, Email table
PhoneEmail
888-526-7738cs@inquismedical.com

Regulatory Flags#

DUNS number
117606791
Device count
1
Lot or batch
true
Expiration date on label
true
Sterilization required before use
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860009303423Powered Aventus Clot Management SystemCMS-PCMS-P2026-10-19
00860009303430Aventus Clot Management SystemCMS-M2026-10-19
00860009303461C02 Cartridge AccessoryCO2-01CO2-012026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmAV16SWP-115-PAV16SWP-115-P2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackCO2-05CO2-052026-10-19
00860014559273Powered Aventus Thrombectomy CatheterAV16SWP-85-P2026-10-19
00860014559204Aventus Introducer SheathAV24S-33AV24S-332026-05-01
00860014559211Aventus Introducer SheathAV16S-13AV16S-132026-05-01
00860014559228Aventus Introducer SheathAV16S-33AV16S-332026-05-01
00860009303447Aventus Thrombectomy SystemAV24MAX-92-M2025-08-20
00860009303416Aventus Thrombectomy System - Clot Management SystemIM-0002CMS-M2024-07-23
00860005664009Isolaer Aerosol Isolation BarrierIB-10002021-02-03

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00810123710126InThrill Thrombectomy CatheterInari Medical, Inc.QEW2025-05-30
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.QEW2025-04-09
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.QEW2024-12-20
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00810123710140ClotTriever CatheterInari Medical, Inc.QEW2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.QEW2024-03-27
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00810123710058ClotTriever SheathInari Medical, Inc.QEW2023-12-15