Device Classification Name |
introducer, catheter
|
510(k) Number |
K123618 |
Device Name |
AXERA 2 ACCESS SYSTEM |
Applicant |
ARSTASIS, INC. |
740 BAY RD |
REDWOOD CITY,
CA
94063
|
|
Applicant Contact |
DEBRA COGAN |
Correspondent |
ARSTASIS, INC. |
740 BAY RD |
REDWOOD CITY,
CA
94063
|
|
Correspondent Contact |
DEBRA COGAN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/23/2012 |
Decision Date | 03/24/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|