Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K934988 |
Device Name |
9 FRENCH LARGE LUMEN TRIGUIDE PLUS GUIDING CATHETER |
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 | 870.1250
|
Classification Product Code |
|
Date Received | 10/18/1993 |
Decision Date | 01/14/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|