Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K131038 |
Device Name |
NMI PICC MAXIMAL BARRIER NURSING KITS |
Applicant |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Applicant Contact |
MARION W GORDON |
Correspondent |
NAVILYST MEDICAL, INC. |
26 FOREST STREET |
MARLBOROUGH,
MA
01752
|
|
Correspondent Contact |
MARION W GORDON |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 04/15/2013 |
Decision Date | 05/09/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|