Device Classification Name |
introducer, catheter
|
510(k) Number |
K091006 |
Device Name |
ITG VASCULAR ACCESS SYSTEM, MODEL 300 |
Applicant |
ARSTASIS, INC. |
1021 HOWARD AVE |
SUITE C |
SAN CARLOS,
CA
94070
|
|
Applicant Contact |
DOMINIQUE FILLOUX |
Correspondent |
ARSTASIS, INC. |
1021 HOWARD AVE |
SUITE C |
SAN CARLOS,
CA
94070
|
|
Correspondent Contact |
DOMINIQUE FILLOUX |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 04/08/2009 |
Decision Date | 02/25/2010 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
Yes
|
Recalls |
CDRH Recalls
|
|
|