Device Classification Name |
Catheter, Angioplasty, Peripheral, Transluminal
|
510(k) Number |
K972512 |
Device Name |
SMASH PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) CARDIOVASCULAR DEVICES PANEL |
Applicant |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Applicant Contact |
RON BENNETT |
Correspondent |
BOSTON SCIENTIFIC SCIMED, INC. |
5905 NATHAN LN. |
MINNEAPOLIS,
MN
55442
|
|
Correspondent Contact |
RON BENNETT |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 07/07/1997 |
Decision Date | 02/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|