Device Classification Name |
Catheter, Continuous Flush
|
510(k) Number |
K081147 |
Device Name |
ISOFLOW INFUSION CATHETER |
Applicant |
VASCULAR DESIGNS INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Applicant Contact |
GRACE HOLLAND |
Correspondent |
VASCULAR DESIGNS INC. |
3722 AVE. SAUSALITO |
IRVINE,
CA
92606
|
|
Correspondent Contact |
GRACE HOLLAND |
Regulation Number | 870.1210
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 04/22/2008 |
Decision Date | 05/29/2009 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|