Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K102728 |
Device Name |
ARSTASIS ACCESS SYSTEM |
Applicant |
ARSTASIS, INC. |
1021 HOWARD AVE |
SUITE C |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
DEBRA COGAN |
Correspondent |
ARSTASIS, INC. |
1021 HOWARD AVE |
SUITE C |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
DEBRA COGAN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/22/2010 |
Decision Date | 10/07/2010 |
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
|
|
|