Device Classification Name |
catheter, intravascular, diagnostic
|
510(k) Number |
K914199 |
Device Name |
ANGIOGRAPHIC SOFT TIP CATHETER |
Applicant |
E-Z-EM, INC. |
P.O. BOX 993 |
266 QUEENSBURY AVENUE |
GLENS FALLS,
NY
12801
|
|
Applicant Contact |
MERRIBETH ADAMS |
Correspondent |
E-Z-EM, INC. |
P.O. BOX 993 |
266 QUEENSBURY AVENUE |
GLENS FALLS,
NY
12801
|
|
Correspondent Contact |
MERRIBETH ADAMS |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 09/19/1991 |
Decision Date | 12/18/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|