Device Classification Name |
Catheter, Continuous Flush
|
510(k) Number |
K090870 |
Device Name |
ECHELON MICRO CATHETER, MODELS 105-5092-150SA, 145-5092-150SA AND 190-5092-150SA AND SYRINGE ADAPTER ACCESSORY |
Applicant |
MICRO THERAPEUTICS, INC. |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Applicant Contact |
TOM DAUGHTERS |
Correspondent |
MICRO THERAPEUTICS, INC. |
9775 TOLEDO WAY |
IRVINE,
CA
92618
|
|
Correspondent Contact |
TOM DAUGHTERS |
Regulation Number | 870.1210
|
Classification Product Code |
|
Date Received | 03/30/2009 |
Decision Date | 05/01/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|