Device Classification Name |
Catheter, Intravascular, Diagnostic
|
510(k) Number |
K862466 |
Device Name |
SCHNEIDER-SHILEY FLUSHING CATHETER |
Applicant |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Applicant Contact |
RADINE POBUDA |
Correspondent |
SHILEY, INC. |
17600 GILLETTE AVE. |
P.O. BOX 19503 |
IRVINE,
CA
92714
|
|
Correspondent Contact |
RADINE POBUDA |
Regulation Number | 870.1200
|
Classification Product Code |
|
Date Received | 06/30/1986 |
Decision Date | 08/29/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|