Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
FDA 510(k) K223929 · Innova Vascular, Inc.
510(k) numberK223929
Submission
- Device name
- Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System)
- Applicant
- Innova Vascular, Inc.
Irvine, CA, US - Received
- December 30, 2022
- Decision date
- June 1, 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 |
Questions and answers
When was Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System) cleared by the FDA?
Laguna Clot Retriever System and Malibu Aspiration Catheter System (Laguna Thrombectomy System) (K223929) received a 510(k) decision of Substantially Equivalent on June 1, 2023, 153 days after the submission was received.
What is the product code of K223929?
The FDA product code is QEW – Peripheral Mechanical Thrombectomy With Aspiration, a Class II (moderate risk) device regulated under 21 CFR 870.5150.