Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K970823 |
Device Name |
SCIMED 8 FRENCH WISEGUIDE GUIDE CATHETER |
Applicant |
SCIMED LIFE SYSTEMS, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
ANGELA RUAN |
Correspondent |
SCIMED LIFE SYSTEMS, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
ANGELA RUAN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 03/06/1997 |
Decision Date | 06/03/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|