Device Classification Name |
Set, Tubing, Blood, With And Without Anti-Regurgitation Valve
|
510(k) Number |
K983559 |
Device Name |
BLOOD TUBING ACCESSORY WITH CLAVE CONNECTOR |
Applicant |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Applicant Contact |
SHERYL SAENZ |
Correspondent |
ICU MEDICAL, INC. |
951 CALLE AMANECER |
SAN CLEMENTE,
CA
92673
|
|
Correspondent Contact |
SHERYL SAENZ |
Regulation Number | 876.5820
|
Classification Product Code |
|
Date Received | 10/13/1998 |
Decision Date | 12/24/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Expedited Review |
Yes
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|