Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K061289 |
Device Name |
ARROW PRESSURE INJECTABLE PICC |
Applicant |
ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
ELIZABETH DUNCAN |
Correspondent |
ARROW INTERNATIONAL, INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
ELIZABETH DUNCAN |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 05/09/2006 |
Decision Date | 08/24/2006 |
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
|
|
|