AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060— 510(k) K041374
Substantially EquivalentIdev Technologies, Inc.
FDA 510(k) clearance K041374 for AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060, Substantially Equivalent on 2005-03-02. Applicant: Idev Technologies, Inc.. Device class: 2.
Clearance details
- Applicant
- Idev Technologies, Inc.
- Product code
- Code QEW
- Device class
- Class 2
- Regulation
- 21 CFR 870.5150
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Houston, TX, US
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Adverse events under product code QEW
product code QEW- Death
- 126
- Injury
- 282
- Malfunction
- 820
- Total
- 1,228
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.