JETi Hydrodynamic Thrombectomy System
FDA 510(k) K243549 · Abbott Medical
510(k) numberK243549
Submission
- Device name
- JETi Hydrodynamic Thrombectomy System
- Applicant
- Abbott Medical
Santa Clara, CA, US - Received
- November 15, 2024
- Decision date
- April 4, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QEZ – Aspiration Thrombectomy Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
To remove thrombus from the peripheral and/or coronary vasculature through aspiration.
Other 510(k)s with product code QEZ
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|---|---|---|---|
| K254035 | Mayumi Thrombectomy SystemQEZ · Traditional | MicroVention, Inc., d/b/a Terumo Neuro | 09/03/2026SE |
| K261105 | Powered Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 07/27/2026SE |
| K262030 | Aventus Thrombectomy SystemQEZ · Special | Inquis Medical | 07/15/2026SE |
| K253589 | Liberant RX Aspiration CatheterQEZ · Traditional | Medtronic Interventional Vascular, Inc. | 04/23/2026SE |
| K254208 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 03/20/2026SE |
| K253925 | Aventus Thrombectomy SystemQEZ · Traditional | Inquis Medical | 01/15/2026SE |
| K252509 | AlphaVac Multipurpose Mechanical Aspiration System F1885QEZ · Traditional | AngioDynamics, Inc. | 11/24/2025SE |
| K251312 | Vesalio Peripheral SystemQEZ · Traditional | Vesalio, Inc. | 10/24/2025SE |
| K251488 | FLOWRUNNER Aspiration SystemQEZ · Special | Expanse Medical, Inc. | 07/14/2025SE |
| K250013 | VentiV 7Fr -12Fr MP Mechanical Thrombectomy System (VS7-MP60S, VS7-MP90S, VS8-MP60S…QEZ · Special | Control Medical Technology, Inc. / Dba Ventiv… | 03/24/2025SE |
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Questions and answers
When was JETi Hydrodynamic Thrombectomy System cleared by the FDA?
JETi Hydrodynamic Thrombectomy System (K243549) received a 510(k) decision of Substantially Equivalent on April 4, 2025, 140 days after the submission was received.
What is the product code of K243549?
The FDA product code is QEZ – Aspiration Thrombectomy Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.5150.