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.
Clearance details
- Applicant
- Jupiter Endovascular
- Product code
- 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 all- K262538 — Artix MT; Artix Thin-Walled Sheath
- K260599 — INDIGO® Aspiration System INDIGO Link
- K251949 — INDIGO® Aspiration System - Lightning Flash Aspiration Tubing with LINK
- K260028 — CLEANER Vac Thrombectomy System, CLEANER Vac Aspiration Catheter with Handpiece, CLEANER Vac Aspiration Canister
- K253730 — RoVo Mechanical Thrombectomy System
More 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.