Device Classification Name |
Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
|
510(k) Number |
K925049 |
Device Name |
QUEST HEART INSULATION PAD |
Applicant |
QUEST MEDICAL, INC. |
4103 BILLY MITCHELL DR. |
DALLAS,
TX
75244
|
|
Applicant Contact |
DREW JOHNSON |
Correspondent |
QUEST MEDICAL, INC. |
4103 BILLY MITCHELL DR. |
DALLAS,
TX
75244
|
|
Correspondent Contact |
DREW JOHNSON |
Regulation Number | 870.4210
|
Classification Product Code |
|
Date Received | 10/06/1992 |
Decision Date | 02/01/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|