Device Classification Name |
catheter, percutaneous
|
510(k) Number |
K961280 |
Device Name |
SCIMED 6-10 F TRIGUIDE GUIDE CATHETERS 6F,7F,8F,9F & 10F |
Applicant |
SCIMED LIFE SYSTEMS, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
ANGELA RAUN |
Correspondent |
SCIMED LIFE SYSTEMS, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
ANGELA RAUN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 04/03/1996 |
Decision Date | 05/15/1996 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|