Angiojet Ultra Avx Thrombectomy Set
FDA 510(k) K133629 · Possis Medical, Inc.
510(k) numberK133629
Submission
- Device name
- Angiojet Ultra Avx Thrombectomy Set
- Applicant
- Possis Medical, Inc.
Minneapolis, MN, US - Received
- November 26, 2013
- Decision date
- February 14, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEW – Peripheral Mechanical Thrombectomy With Aspiration
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To mechanically disrupt thrombus and/or debris prior to removal from the peripheral vasculature through aspiration.
Other 510(k)s with product code QEW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261800 | Helo Max Thrombectomy System (HEL2090)QEW · Traditional | Endovascular Engineering | 09/03/2026SE |
| K262538 | Artix MT;Artix Thin-Walled SheathQEW · Special | Inari Medical, Inc. | 08/21/2026SE |
| K261523 | Vertex Thrombectomy SystemQEW · Traditional | Jupiter Endovascular | 08/04/2026SE |
| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | Penumbra, Inc. | 04/24/2026SE |
| K260028 | CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece…QEW · Special | Argon Medical Devices, Inc. | 02/05/2026SE |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | Penumbra, Inc. | 02/05/2026SE |
| K253730 | RoVo Mechanical Thrombectomy SystemQEW · Special | Verge Medical, Inc. | 01/21/2026SE |
| K251207 | Sangria Thrombectomy SystemQEW · Traditional | Avantec Vascular Corporation | 01/07/2026SE |
| K252956 | Helo Thrombectomy SystemQEW · Traditional | Endovascular Engineering, Inc. | 12/18/2025SE |
| K251070 | Akura Thrombectomy SystemQEW · Traditional | Akura Medical | 11/25/2025SE |
More from Akura Medical
| 510(k) | Device | Decision |
|---|---|---|
| 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 |
| K073441 | Angiojet Ultra Avx Thrombectomy Set, Model 105039QEZ · Traditional | 01/24/2008SE |
| 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 cleared by the FDA?
Angiojet Ultra Avx Thrombectomy Set (K133629) received a 510(k) decision of Substantially Equivalent on February 14, 2014, 80 days after the submission was received.
What is the product code of K133629?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.