Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K810675 |
Device Name |
ARROW RADIAL ARTERY CATHETERIZATION SET |
Applicant |
ARROW INTL., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
ARROW INTL., INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 03/12/1981 |
Decision Date | 03/27/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|