Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K964518 |
FOIA Releasable 510(k) |
K964518
|
Device Name |
FAST-CATH TRANSSEPTAL CATHETER INTRODUCER |
Applicant |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Applicant Contact |
JOHN C HEINMILLER |
Correspondent |
DAIG CORP. |
14901 DEVEAU PLACE |
MINNETONKA,
MN
55345 -2126
|
|
Correspondent Contact |
JOHN C HEINMILLER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 10/25/1996 |
Decision Date | 05/14/1997 |
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
|
|
|