AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060— 510(k) K030504

Substantially Equivalent

Idev Technologies, Inc.

FDA 510(k) clearance K030504 for AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060, Substantially Equivalent on 2003-09-16. Applicant: Idev Technologies, Inc..

Clearance details

Applicant: Idev Technologies, Inc.
Product code: Code MCW
Advisory panel: Cardiovascular
Date received: 2003-02-19
Decision date: 2003-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Houston, TX, US

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Adverse events under product code MCW

product code MCW

Death: 38
Injury: 1,386
Malfunction: 2,676
Other: 2
Total: 4,102

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.