Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K032962 |
Device Name |
AC 3 LUMEN CENTRAL VENOUS ACCESS KIT WITH ARROWG+ARD ANTIMICROBIAL SURFACE |
Applicant |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Applicant Contact |
ELIZABETH PRICE |
Correspondent |
ARROW INTL., INC. |
2400 BERNVILLE RD. |
READING,
PA
19605
|
|
Correspondent Contact |
ELIZABETH PRICE |
Regulation Number | 880.5200
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/23/2003 |
Decision Date | 10/29/2003 |
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 |
Yes
|
|
|