510(k) Premarket Notification Database
Device Classification Name |
electrode, pacemaker, permanent
|
510(k) Number | K955550 |
Device Name | CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD |
Applicant |
INTERMEDICS, INC.
|
4000 technology dr. |
angleton,
TX
77515 |
|
Contact | lori kleinschrodt holder |
Regulation Number | 870.3680 |
Classification Product Code |
|
Date Received | 12/05/1995 |
Decision Date | 06/19/1996 |
Decision |
se subject to tracking reg (ST) |
Classification Advisory Committee |
Cardiovascular
|
Review Advisory Committee |
Cardiovascular
|
Statement/Summary/Purged Status |
Summary only
|
summary |
summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
|
|
|