Device Classification Name |
introducer, catheter
|
510(k) Number |
K120158 |
Device Name |
CORONARY SINUS GUIDE AND LATERAL VEIN INTRODUCER KITS |
Applicant |
THOMAS MEDICAL PRODUCTS, INC. |
65 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Applicant Contact |
TIM STOUDT |
Correspondent |
THOMAS MEDICAL PRODUCTS, INC. |
65 GREAT VALLEY PKWY. |
MALVERN,
PA
19355
|
|
Correspondent Contact |
TIM STOUDT |
Regulation Number | 870.1340
|
Classification Product Code |
|
Date Received | 01/18/2012 |
Decision Date | 08/14/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|