Device Classification Name |
administrations sets with neuraxial connectors
|
510(k) Number |
K162219 |
Device Name |
CADD® Infusion Disposables Portfolio with NRFit™ connectors |
Applicant |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Applicant Contact |
Wendy J. Kivens |
Correspondent |
Smiths Medical ASD, Inc. |
6000 Nathan Lane North |
Minneapolis,
MN
55442
|
|
Correspondent Contact |
Michael Johnson |
Regulation Number | 880.5440
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 08/08/2016 |
Decision Date | 07/20/2017 |
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
|
|
|