Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K000956 |
Device Name |
MODIFICATION TO SCIMED 6F IMPULSE ANGIOGRAPHIC CATHATERS |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Applicant Contact |
MELANIE RASKA |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIMED PLACE |
MAPLE GROVE,
MN
55311
|
|
Correspondent Contact |
MELANIE RASKA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 03/24/2000 |
Decision Date | 04/21/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|