Device Classification Name |
introducer, catheter
|
510(k) Number |
K043525 |
Device Name |
CATHETER INTRODUCER |
Applicant |
GALT MEDICAL CORP. |
2475 MERRITT DR. |
GARLAND,
TX
75041
|
|
Applicant Contact |
DAVID CATLIN |
Correspondent |
GALT MEDICAL CORP. |
2475 MERRITT DR. |
GARLAND,
TX
75041
|
|
Correspondent Contact |
DAVID CATLIN |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 12/21/2004 |
Decision Date | 02/09/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|