Device Classification Name |
catheter, intravascular, therapeutic, long-term greater than 30 days
|
510(k) Number |
K113277 |
Device Name |
ARROWADVANTAGES PRESSURE INJECTABLE PERIPHERALLY INSCRTED CENTRAL CATHETER KITS |
Applicant |
ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
TRACY MADDOCK |
Correspondent |
ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
TRACY MADDOCK |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 11/07/2011 |
Decision Date | 06/21/2012 |
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
|
|
|