Aventus Thrombectomy System - Clot Management System
- Primary DI
- 00860009303416
- Brand
- Aventus Thrombectomy System - Clot Management System
- Company
- Inquis Medical, Inc.
- Model
- IM-0002
- Device description
- The Aventus Clot Management System is connected to the aspiration syringe and is used to filter and return blood to the patient as desired. The clot canister contains a coarse pre-filter to separate blood from clot and is designed to be compatible with off-the-shelf blood transfusion filters.
- Published
- 2024-07-23
- 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 |
|---|
| CAC | Apparatus, Autotransfusion |
Product Code Classifications
| Code | Device | Specialty | Class |
|---|
| CAC | Apparatus, Autotransfusion | Anesthesiology | 2 |
Premarket Details
| Submission | Supplement | Device | Applicant | Decision date | Product code |
|---|
| K240426 | 000 | Aventus Clot Management System | Inquis Medical | 2024-05-14 | CAC |
Identifiers And Packaging
| Identifier | Type | Agency | Package quantity | Status |
|---|
| 00860009303416 | Primary | GS1 | 0 | |
GMDN Terms
| 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. |
Contacts
| Phone | Email |
|---|
| 888-526-7738 | cs@inquismedical.com |
Regulatory Flags
- DUNS number
- 117606791
- 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
- true
Other Devices From This Company
| Primary DI | Brand | Model | Catalog | Published |
|---|
| 00860009303447 | Aventus Thrombectomy System | AV24MAX-92-M | | 2025-08-20 |
| 00860009303409 | Aventus Thrombectomy System - Aspiration Catheter | IM-2001 | | 2024-07-23 |
| 00860005664009 | Isolaer Aerosol Isolation Barrier | IB-1000 | | 2021-02-03 |
Other Devices Sharing Product Codes