Device Classification Name |
catheter, continuous flush
|
510(k) Number |
K031992 |
Device Name |
ECHELON MICRO CATHETER, MODEL 105-5091 |
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 | 06/27/2003 |
Decision Date | 08/07/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|