Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K000570 |
Device Name |
BLUE MAX BALLOON DILATATION CATHETER, MAXFORCE BALLOON CATHETER, XXL BALLOON DILATATION CATHATER, SYMMETRY BALLOON DILA |
Applicant |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Applicant Contact |
TERRY A MCGOVERN |
Correspondent |
BOSTON SCIENTIFIC CORP. |
One Boston Scientific Place |
Natick,
MA
01760
|
|
Correspondent Contact |
TERRY A MCGOVERN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 02/22/2000 |
Decision Date | 04/13/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|