Device Classification Name |
Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection
|
510(k) Number |
K910917 |
Device Name |
CATHLAB SILICONE BILIARY BALLOON CATHETER |
Applicant |
CATHLAB CORP. |
17991 FITCH |
IRVINE,
CA
92714
|
|
Applicant Contact |
DANIEL R LUCAS |
Correspondent |
CATHLAB CORP. |
17991 FITCH |
IRVINE,
CA
92714
|
|
Correspondent Contact |
DANIEL R LUCAS |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 03/05/1991 |
Decision Date | 08/02/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|