Device Classification Name |
introducer, catheter
|
510(k) Number |
K990705 |
Device Name |
MEDAMICUS COAXIAL INTRODUCER KIT, 10330-XXX, BOSTON SCIENTIFIC COAXIAL DILATOR SET |
Applicant |
MEDAMICUS, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Applicant Contact |
DENNIS S MADISON |
Correspondent |
MEDAMICUS, INC. |
15301 HWY. 55 WEST |
MINNEAPOLIS,
MN
55447
|
|
Correspondent Contact |
DENNIS S MADISON |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 03/04/1999 |
Decision Date | 06/28/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|