AKONYA ELIMINATOR MECHANICAL THROMBECTOMY DEVICE, MODEL EL 10060060


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

Correspodent Contact lynne a davies
Regulation Number 870.4875
Classification Product Code
MCW  
Date Received 02/19/2003
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