Device Classification Name |
catheter, cannula and tubing, vascular, cardiopulmonary bypass
|
510(k) Number |
K042984 |
Device Name |
INTERGARD WOVEN CONNECTOR GRAFT, MODEL IGW0030-10C |
Applicant |
INTERVASCULAR |
690 CANTON STREET |
SUITE 302 |
WESTWOOD,
MA
02090
|
|
Applicant Contact |
Amy Aulwes |
Correspondent |
INTERVASCULAR |
690 CANTON STREET |
SUITE 302 |
WESTWOOD,
MA
02090
|
|
Correspondent Contact |
Amy Aulwes |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/29/2004 |
Decision Date | 02/18/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|