Device Classification Name |
adaptor, stopcock, manifold, fitting, cardiopulmonary bypass
|
510(k) Number |
K072745 |
Device Name |
Y-GLIDE |
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 | 870.4290
|
Classification Product Code |
|
Date Received | 09/27/2007 |
Decision Date | 01/04/2008 |
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
|
|
|