Angiojet Ultra Avx Thrombectomy Set, Model 105039
FDA 510(k) K073441 · Possis Medical, Inc.
510(k) numberK073441
Submission
- Device name
- Angiojet Ultra Avx Thrombectomy Set, Model 105039
- Applicant
- Possis Medical, Inc.
Minneapolis, MN, US - Received
- December 7, 2007
- Decision date
- January 24, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEZ – Aspiration Thrombectomy Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Other 510(k)s with product code QEZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K254035 | Mayumi Thrombectomy SystemQEZ · Traditional | MicroVention, Inc., d/b/a Terumo Neuro | 09/03/2026SE |
| K261105 | Powered Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 07/27/2026SE |
| K262030 | Aventus Thrombectomy SystemQEZ · Special | Inquis Medical | 07/15/2026SE |
| K253589 | Liberant RX Aspiration CatheterQEZ · Traditional | Medtronic Interventional Vascular, Inc. | 04/23/2026SE |
| K254208 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 03/20/2026SE |
| K253925 | Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 01/15/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | AngioDynamics, Inc. | 11/24/2025SE |
| K251312 | Vesalio Peripheral SystemQEZ · Traditional | Vesalio, Inc. | 10/24/2025SE |
| K251488 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 07/14/2025SE |
| K243549 | JETi Hydrodynamic Thrombectomy SystemQEZ · Traditional | Abbott Medical | 04/04/2025SE |
More from Abbott Medical
| 510(k) | Device | Decision |
|---|---|---|
| K133629 | Angiojet Ultra Avx Thrombectomy SetQEW · Special | 02/14/2014SE |
| K091593 | Angio Jet Ultra DVX and Xpeedior Thrombectomy SetsQEZ · Special | 06/22/2009SE |
| K090253 | Angiojet Ultra DVX Thrombectomy Set, Model 106552-001, Angiojet Ultra Xpeedior…QEZ · Traditional | 04/08/2009SE |
| K082382 | Angiojet Ultra Avx Thrombectomy Set, Model 105039QEZ · Traditional | 12/12/2008SE |
| K081989 | Modification to Fetch Aspiration CatheterQEZ · Special | 09/26/2008SE |
| K081454 | Guarddog Occlusion Guidewire, Inflation DeviceMJN · Special | 06/13/2008SE |
| K080806 | Angiojet Ultra Spiroflex VG Thrombectomy Set, Model 106608QEZ · Traditional | 04/04/2008SE |
| K072769 | Angiojet Ultra; Xmi (105041), XVG (105042) and Spiroflex (106553) Thrombectomy SetsQEZ · Traditional | 11/14/2007SE |
| K072269 | Angiojet Ultra DVX Thrombectomy Set, Model: 106552QEZ · Traditional | 09/08/2007SE |
| K071336 | Angiojet Xpeedior Rheolytic Thrombectomy Catheter, Model 104307QEZ · Traditional | 08/24/2007SE |
Questions and answers
When was Angiojet Ultra Avx Thrombectomy Set, Model 105039 cleared by the FDA?
Angiojet Ultra Avx Thrombectomy Set, Model 105039 (K073441) received a 510(k) decision of Substantially Equivalent on January 24, 2008, 48 days after the submission was received.
What is the product code of K073441?
The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.