Device Classification Name |
catheter, angioplasty, peripheral, transluminal
|
510(k) Number |
K122379 |
Device Name |
FLASH PTA BALLOON DILATATION CATHETER - 4MM X 14MM X 135CM, FLASH PTA BALLOON DILATATION CATHETER - 4MM X 19MM X 135CM |
Applicant |
OSTIAL CORPORATION |
510 CLYDE AVENUE |
MOUNTAIN VIEW,
CA
94043
|
|
Applicant Contact |
KAITLIN VON HOFFMANN |
Correspondent |
OSTIAL CORPORATION |
510 CLYDE AVENUE |
MOUNTAIN VIEW,
CA
94043
|
|
Correspondent Contact |
KAITLIN VON HOFFMANN |
Regulation Number | 870.1250
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/06/2012 |
Decision Date | 09/05/2012 |
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
|
|
|