Socrates Aspiration System (Socrates 70 Aspiration Catheter)— 510(k) K260002

Substantially Equivalent

Scientia Vascular, Inc.

FDA 510(k) clearance K260002 for Socrates Aspiration System (Socrates 70 Aspiration Catheter), Substantially Equivalent on 2026-07-16. Applicant: Scientia Vascular, Inc..

Clearance details

Applicant: Scientia Vascular, Inc.
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2026-01-02
Decision date: 2026-07-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Valley City, UT, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code NRY

product code NRY

Death: 411
Injury: 1,712
Malfunction: 1,855
Total: 3,978

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.