CAPERE Thrombectomy System— 510(k) K180722

Substantially Equivalent

Kp Medcure, Inc.

FDA 510(k) clearance K180722 for CAPERE Thrombectomy System, Substantially Equivalent on 2018-06-11. Applicant: Kp Medcure, Inc..

Clearance details

Applicant: Kp Medcure, Inc.
Product code: Code QEW
Advisory panel: Cardiovascular
Date received: 2018-03-19
Decision date: 2018-06-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Anaheim, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code QEW

product code QEW

Death: 126
Injury: 282
Malfunction: 820
Total: 1,228

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.