Device Classification Name |
Catheter, Percutaneous
|
510(k) Number |
K923245 |
Device Name |
TRIGUIDE-PLUS GUIDING CATHETER |
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 | 870.1250
|
Classification Product Code |
|
Date Received | 07/02/1992 |
Decision Date | 02/12/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|