Device Classification Name |
catheter, irrigation
|
510(k) Number |
K925533 |
Device Name |
ANGESTAT(R) PERICARDIAL DRAINAGE SHEATH SET |
Applicant |
ANGEION CORP. |
13000 HIGHWAY 55 |
PLYMOUTH,
MN
55441
|
|
Applicant Contact |
BRUCE D HENKE |
Correspondent |
ANGEION CORP. |
13000 HIGHWAY 55 |
PLYMOUTH,
MN
55441
|
|
Correspondent Contact |
BRUCE D HENKE |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 11/02/1992 |
Decision Date | 01/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|