Device Classification Name |
introducer, catheter
|
510(k) Number |
K123430 |
Device Name |
MICROSLIDER TEARAWAY INTRODUCER SET |
Applicant |
GALT MEDICAL CORP. |
2220 MERRITT DR. |
GARLAND,
TX
75041
|
|
Applicant Contact |
DAVID DERRICK |
Correspondent |
GALT MEDICAL CORP. |
2220 MERRITT DR. |
GARLAND,
TX
75041
|
|
Correspondent Contact |
DAVID DERRICK |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 11/07/2012 |
Decision Date | 04/12/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|