Socrates Aspiration System (Socrates 70 Aspiration Catheter)— 510(k) K260002
Substantially EquivalentScientia 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.. Device class: 2.
Summary
Scientia Vascular's Socrates Aspiration System (Socrates 70 Aspiration Catheter) is filed under NRY, thrombus retriever catheters. The record doesn't give catheter dimensions.
Class II, 21 CFR 870.1250. The Neurology review panel handled it as a Traditional 510(k), though the record lists Cardiovascular as the classification panel.
Scientia Vascular filed from West Valley City, Utah. Review took 195 calendar days (January 2 to July 16, 2026).
Clearance details
- Applicant
- Scientia Vascular, Inc.
- Product code
- Product code NRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.1250
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Valley City, UT, US
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More clearances from Scientia Vascular, Inc.
view allAdverse events under product code NRY
product code NRY- Death
- 411
- Injury
- 1,712
- Malfunction
- 1,855
- Total
- 3,978
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.