Aventus Thrombectomy System - Aspiration Catheter

GUDID 00860009303409

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.

Inquis Medical, Inc.

Thrombectomy suction catheter
Primary Device ID00860009303409
NIH Device Record Key9a69936b-a7a4-438b-95cd-afad1fe9be34
Commercial Distribution StatusIn Commercial Distribution
Brand NameAventus Thrombectomy System - Aspiration Catheter
Version Model NumberIM-2001
Company DUNS117606791
Company NameInquis Medical, Inc.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com
Phone888-526-7738
Emailcs@inquismedical.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100860009303409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


[00860009303409]

Ethylene Oxide


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-31
Device Publish Date2024-07-23

Devices Manufactured by Inquis Medical, Inc.

00860009303409 - Aventus Thrombectomy System - Aspiration Catheter2024-07-31The 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.
00860009303409 - Aventus Thrombectomy System - Aspiration Catheter2024-07-31 The Aventus Aspiration Catheter is a multi-lumen catheter with a flexible shaft and a tapered radiopaque tip designed to remove
00860009303416 - Aventus Thrombectomy System - Clot Management System2024-07-31 The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient
00860005664009 - Isolaer Aerosol Isolation Barrier2021-02-11 The IB Device is a procedure site barrier (i.e. drape) that surrounds a surgical site that minimizes exposure of aerosols during

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