Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K992123 |
Device Name |
SCIMED IMPULSE ANGIOGRAPHIC CATHETERS |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIEMD PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Applicant Contact |
MELANIE RASKA |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
ONE SCIEMD PLACE |
MAPLE GROVE,
MN
55311 -1566
|
|
Correspondent Contact |
MELANIE RASKA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 06/23/1999 |
Decision Date | 08/23/1999 |
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
|
|
|