Device Classification Name |
Wire, Guide, Catheter
|
510(k) Number |
K760944 |
Device Name |
ANGIOGRAPHIC GUIDEWIRE |
Applicant |
MEDRAD, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
MEDRAD, INC. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1330
|
Classification Product Code |
|
Date Received | 11/01/1976 |
Decision Date | 12/10/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|