Device Classification Name |
introducer, catheter
|
510(k) Number |
K954317 |
Device Name |
DIAG FAST-CATH DUO & TRIO REMOVABLE HEMOSTASIS ADAPTERS W/SIDEPORTS & 3-WAY STOPCOCKS |
Applicant |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
JOHN J FLEISCHHACKER |
Correspondent |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
JOHN J FLEISCHHACKER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 09/15/1995 |
Decision Date | 11/28/1995 |
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
|
|
|