Device Classification Name |
set, administration, intravascular
|
510(k) Number |
K974589 |
Device Name |
SMARTVALVE |
Applicant |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
SALVADORE F PALOMARES |
Correspondent |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
SALVADORE F PALOMARES |
Regulation Number | 880.5440
|
Classification Product Code |
|
Date Received | 12/09/1997 |
Decision Date | 01/09/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|