Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K934541 |
Device Name |
SCIMED 6 FRENCH ANGIOGRAPHIC CATHETER MODIFICATION |
Applicant |
SCIMED LIFE SYSTEMS, INC. |
2010 EAST CENTER CIRCLE |
PLYMOUTH,
MN
55441 -2644
|
|
Applicant Contact |
DEBORAH L JENSEN |
Correspondent |
SCIMED LIFE SYSTEMS, INC. |
2010 EAST CENTER CIRCLE |
PLYMOUTH,
MN
55441 -2644
|
|
Correspondent Contact |
DEBORAH L JENSEN |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/16/1993 |
Decision Date | 05/12/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|