Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K042187 |
Device Name |
ECHELON 10,45 TIP SHAPE MICRO CATHETER ECHELON 10,90 TIP SHAPE MICRO CATHETER, ECHELON 14,45 TIP SHAPE MICRO CATHETER,90 |
Applicant |
MICRO THERAPEUTICS, INC. |
2 GOODYEAR |
IRVINE,
CA
92618
|
|
Applicant Contact |
MARILYN R POURAZAR |
Correspondent |
MICRO THERAPEUTICS, INC. |
2 GOODYEAR |
IRVINE,
CA
92618
|
|
Correspondent Contact |
MARILYN R POURAZAR |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 08/12/2004 |
Decision Date | 09/02/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|