Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K924558 |
Device Name |
ARROW BLOOD CONTAINMENT DEVICE |
Applicant |
ARROW INTL., INC. |
P.O. BOX 12888 |
3000 BERNVILLE RD |
READING,
PA
19612
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
P.O. BOX 12888 |
3000 BERNVILLE RD |
READING,
PA
19612
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 870.1330
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/09/1992 |
Decision Date | 08/19/1993 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|