Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K163452 |
Device Name |
PICC Maximal Barrier Nursing Kit |
Applicant |
Navilyst Medical, Inc. |
26 Forest Street |
Marlborough,
MA
01752
|
|
Applicant Contact |
Robin Fuller |
Correspondent |
Navilyst Medical, Inc. |
26 Forest Street |
Marlborough,
MA
01752
|
|
Correspondent Contact |
Robin Fuller |
Regulation Number | 880.5970
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/09/2016 |
Decision Date | 02/03/2017 |
Decision |
Substantially Equivalent - Kit
(SESK) |
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
|
|
|