Device Classification Name |
introducer, catheter
|
510(k) Number |
K981782 |
Device Name |
LOW PROFILE PORT ATTACHABLE CATHETER WITH BLUE FLEX TIP / 8FR. INRODUCER KIT IMPLANTABLE VASCULAR ACCESS SYSTEM |
Applicant |
ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY |
WALPOLE,
MA
02081
|
|
Applicant Contact |
BRADLEY J ENEGREN |
Correspondent |
ARROW INTL., INC. |
1600 PROVIDENCE HIGHWAY |
WALPOLE,
MA
02081
|
|
Correspondent Contact |
BRADLEY J ENEGREN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 05/20/1998 |
Decision Date | 08/12/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|