Device Classification Name |
introducer, catheter
|
510(k) Number |
K022003 |
Device Name |
TITAN MICRO CATHETER, MODEL 105-5074-153; HD INJECTOR, MODEL 103-0305 |
Applicant |
MICRO THERAPEUTICS, INC. |
2 GOODYEAR |
IRVINE,
CA
92618
|
|
Applicant Contact |
Bill Hyatt |
Correspondent |
MICRO THERAPEUTICS, INC. |
2 GOODYEAR |
IRVINE,
CA
92618
|
|
Correspondent Contact |
Bill Hyatt |
Regulation Number | 870.1340
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 06/19/2002 |
Decision Date | 09/13/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|