Esperance Aspiration Catheter System— 510(k) K211697

Substantially Equivalent

Wallaby Medical

FDA 510(k) clearance K211697 for Esperance Aspiration Catheter System, Substantially Equivalent on 2021-11-16. Applicant: Wallaby Medical.

Clearance details

Applicant: Wallaby Medical
Product code: Code NRY
Advisory panel: Cardiovascular
Date received: 2021-06-03
Decision date: 2021-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.