FDA 510(k)

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060

K-Number: K041374 · 2005-03-02

Decision Date2005-03-02

Product CodeQEW

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 is the device name listed in this FDA 510(k) record. The listed applicant is Idev Technologies, Inc.. It received FDA 510(k) clearance on 2005-03-02 under 510(k) number K041374. The device is classified under product code QEW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060?

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 is a medical device that received FDA 510(k) clearance on 2005-03-02. The listed applicant is Idev Technologies, Inc.. The 510(k) number is K041374.

When did AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 receive FDA 510(k) clearance?

AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 received FDA 510(k) clearance on 2005-03-02, under 510(k) number K041374.

Who is the listed applicant for AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060?

The FDA 510(k) record lists Idev Technologies, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060?

The FDA product code for AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL10060060 is QEW.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.