Pounce Thrombectomy System
FDA 510(k) K231022 · Surmodics,Inc.
510(k) numberK231022
Submission
- Device name
- Pounce Thrombectomy System
- Applicant
- Surmodics,Inc.
Eden Prairie, MN, US - Received
- April 10, 2023
- Decision date
- June 12, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 |
|---|---|---|
| K252227 | Pounce(TM) SheathDYB · Special | 09/24/2025SE |
| K241362 | Pounce XL Thrombectomy System (PTS-1011-7F135)QEW · Traditional | 09/11/2024SE |
| K232647 | MicrocatheterDQY · Special | 09/29/2023SE |
| K231828 | Pounce SheathDYB · Traditional | 09/07/2023SE |
| K221886 | Sublime MicrocatheterDQY · Traditional | 10/14/2022SE |
| K220501 | Pounce Thrombectomy SystemQEW · Special | 03/23/2022SE |
| K211492 | Pounce Thrombectomy SystemQEW · Traditional | 07/30/2021SE |
| K192814 | Pounce Thrombus Retrieval SystemQEW · Traditional | 09/21/2020SE |
| K190644 | Guide SheathDYB · Traditional | 04/18/2019SE |
| K173560 | MicrocatheterDQY · Traditional | 01/12/2018SE |
Questions and answers
When was Pounce Thrombectomy System cleared by the FDA?
Pounce Thrombectomy System (K231022) received a 510(k) decision of Substantially Equivalent on June 12, 2023, 63 days after the submission was received.
What is the product code of K231022?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.