Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K042182 |
Device Name |
Y CLAVE CONNECTOR WITH INTEGRATED CHECK VALVE, MODEL XI-3432 |
Applicant |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
DALE FAIRCHILD |
Correspondent |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
DALE FAIRCHILD |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 08/11/2004 |
Decision Date | 09/01/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|