Device Classification Name |
Port & Catheter, Implanted, Subcutaneous, Intravascular
|
510(k) Number |
K003006 |
Device Name |
TWO-LUMEN PICC WITH BLUE FLEXTIP CATHETER AND INTEGRAL NEEDLE PROTECTION |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 09/26/2000 |
Decision Date | 10/27/2000 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|