Device Classification Name |
Introducer, Catheter
|
510(k) Number |
K791129 |
Device Name |
PERMANENT LEAD INTRADUCER |
Applicant |
DAIG CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
DAIG CORP. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 06/14/1979 |
Decision Date | 07/17/1979 |
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
|
|
|