Device Classification Name |
biliary catheter for stone removal that may also allow for irrigation and contrast injection
|
510(k) Number |
K915129 |
Device Name |
CATHETER WITH INTRODUCER AND SYRINGES |
Applicant |
UTAH PIONEER MEDICAL, INC. |
P.O.BOX 1163 |
1386 W.CENTER STREET |
OREM,
UT
84057
|
|
Applicant Contact |
WILLIAM D.J.WALLIS |
Correspondent |
UTAH PIONEER MEDICAL, INC. |
P.O.BOX 1163 |
1386 W.CENTER STREET |
OREM,
UT
84057
|
|
Correspondent Contact |
WILLIAM D.J.WALLIS |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 11/13/1991 |
Decision Date | 04/08/1992 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|