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 Number | 870.4875
|
Classification Product Code |
|
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
|
|
|