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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, peripheral, atherectomy
510(k) Number K030504
Device Name AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060
Applicant
IDEV TECHNOLOGIES, INC.
1110 NASA RD., SUITE 311
houston,  TX  77058 -3345
Applicant Contact lynne a davies
Correspondent
IDEV TECHNOLOGIES, INC.
1110 NASA RD., SUITE 311
houston,  TX  77058 -3345
Correspondent Contact lynne a davies
Regulation Number870.4875
Classification Product Code
MCW  
Date Received02/19/2003
Decision Date 09/16/2003
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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