Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K982187 |
Device Name |
FAST-CATH INTRA-CARDIAC INTRODUCER |
Applicant |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
DEAN BRUHN-DING |
Correspondent |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
DEAN BRUHN-DING |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/22/1998 |
Decision Date | 09/16/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|