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
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
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
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13
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
00812339030760Pounce ™ LP ThrombectomySurmodics, Inc.QEW2024-03-19
00810123710430ClotTriever Sheath, 16 FrInari Medical, Inc.QEW2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.QEW2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.QEW2023-10-27
00812339030784Pounce ™ ThrombectomySurmodics, Inc.QEW2023-08-16
00850291007277ClotTriever XL CatheterInari Medical, Inc.QEW2023-05-09
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007321Artix BGInari Medical, Inc.QEW2023-05-09
00850291007376Artix™ AXInari Medical, Inc.QEW2023-04-24
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.QEW2022-06-22
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22