Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
FDA 510(k) K142870 · Penumbra, Inc.
510(k) numberK142870
Submission
- Device name
- Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]
- Applicant
- Penumbra, Inc.
Alameda, CA, US - Received
- October 1, 2014
- Decision date
- May 26, 2015
- 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 |
|---|---|---|
| K250690 | Penumbra System (Thunderbolt Aspiration Tubing)NRY · Traditional | 06/10/2026SE |
| K260599 | INDIGO® Aspiration System INDIGO LinkQEW · Traditional | 04/24/2026SE |
| K251949 | INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINKQEW · Traditional | 02/05/2026SE |
| K252612 | INDIGO® Aspiration System Lightning Flash Aspiration Tubing; INDIGO® Aspiration System…QEW · Traditional | 10/16/2025SE |
| K250079 | Ruby XL SystemKRD · Traditional | 03/14/2025SE |
| K242104 | Penumbra System (Reperfusion Catheter RED 72)NRY · Traditional | 02/13/2025SE |
| K242033 | Access25 Delivery MicrocatheterQJP · Traditional | 12/11/2024SE |
| K242520 | Element Vascular Access SystemDYB · Traditional | 11/20/2024SE |
| K242075 | Indigo® Aspiration System Lightning Bolt Aspiration TubingQEW · Traditional | 09/25/2024SE |
| K242319 | Indigo® Aspiration System Aspiration Catheter 6XQEW · Special | 09/03/2024SE |
Questions and answers
When was Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] cleared by the FDA?
Penumbra Embolectomy Aspiration System [INDIGO Aspiration System] (K142870) received a 510(k) decision of Substantially Equivalent on May 26, 2015, 237 days after the submission was received.
What is the product code of K142870?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.