Device Classification Name |
catheters, transluminal coronary angioplasty, percutaneous
|
510(k) Number |
K152485 |
Device Name |
FLASH Mini Ostial System - 3.0mm x 8mm x 135cm, FLASH Mini Ostial System - 3.5mm x 8mm x 135cm, FLASH Mini Ostial System - 4.0mm x 8mm x 135cm, FLASH Mini Ostial System - 4.5mm x 8mm x 135cm |
Applicant |
OSTIAL CORPORATION |
1221 INNSBRUCK DRIVE |
SUNNYVALE,
CA
94089
|
|
Applicant Contact |
JAKE WOLENBERG |
Correspondent |
OSTIAL CORPORATION |
1221 INNSBRUCK DRIVE |
SUNNYVALE,
CA
94089
|
|
Correspondent Contact |
JAKE WOLENBERG |
Regulation Number | 870.5100
|
Classification Product Code |
|
Date Received | 08/31/2015 |
Decision Date | 02/16/2016 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|