Vertex Thrombectomy System— 510(k) K261523
Substantially EquivalentJupiter Endovascular
FDA 510(k) clearance K261523 for Vertex Thrombectomy System, Substantially Equivalent on 2026-08-04. Applicant: Jupiter Endovascular. Device class: 2.
Summary
Jupiter Endovascular's Vertex Thrombectomy System is filed under product code QEW, peripheral mechanical thrombectomy with aspiration. The record gives no model numbers.
Class II, 21 CFR 870.5150. Cardiovascular is both the classification panel and the review panel. The submission was a Traditional 510(k).
Jupiter filed from Menlo Park, California. The decision came 89 calendar days after FDA received it (May 7 to August 4, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Jupiter Endovascular
- Product code
- Product code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Menlo Park, CA, US
Recent devices under product code QEW
view allMore clearances from Jupiter Endovascular
view allAdverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.