Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
FDA 510(k) K251185 · Intervene
510(k) numberK251185
Submission
- Device name
- Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020)
- Applicant
- Intervene
Redwood City, CA, US - Received
- April 16, 2025
- Decision date
- October 22, 2025
- 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 |
|---|---|---|
| K222185 | Stratus Infusion CatheterNPG · Traditional | 04/13/2023SE |
Questions and answers
When was Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) cleared by the FDA?
Recana Thrombectomy Catheter System (FG014. FG015, FG016, FG017, FG018, FG019, FG020) (K251185) received a 510(k) decision of Substantially Equivalent on October 22, 2025, 189 days after the submission was received.
What is the product code of K251185?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.