Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K914312 |
Device Name |
SCIMED 7FR AND 8FR TRIGUIDE GUIDING CATHETERS |
Applicant |
SCIMED LIFE SYSTEMS, INC. |
6655 WEDGWOOD RD. |
MAPLE GROVE,
MN
55369
|
|
Applicant Contact |
MERCEDES P BAYANI |
Correspondent |
SCIMED LIFE SYSTEMS, INC. |
6655 WEDGWOOD RD. |
MAPLE GROVE,
MN
55369
|
|
Correspondent Contact |
MERCEDES P BAYANI |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/26/1991 |
Decision Date | 11/22/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|