Device Classification Name |
introducer, catheter
|
510(k) Number |
K960200 |
Device Name |
INTROSTAT LEAD INTRODUCER |
Applicant |
MSI, INC. |
615 JASMINE AVENUE N. |
TARPON SPRINGS,
FL
34689
|
|
Applicant Contact |
LARRY G JUNKER |
Correspondent |
MSI, INC. |
615 JASMINE AVENUE N. |
TARPON SPRINGS,
FL
34689
|
|
Correspondent Contact |
LARRY G JUNKER |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 01/03/1996 |
Decision Date | 07/02/1996 |
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
|
|
|