Device Classification Name |
catheter, percutaneous, cutting/scoring
|
510(k) Number |
K072225 |
Device Name |
ANGIOSCULPT PTA SCORING BALLOON CATHETER |
Applicant |
ANGIOSCORE, INC. |
5055 BRANDIN COURT |
FREMONT,
CA
94538
|
|
Applicant Contact |
MELINDA SWANSON |
Correspondent |
ANGIOSCORE, INC. |
5055 BRANDIN COURT |
FREMONT,
CA
94538
|
|
Correspondent Contact |
MELINDA SWANSON |
Regulation Number | 870.1250
|
Classification Product Code |
|
Date Received | 08/10/2007 |
Decision Date | 10/12/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|