Device Classification Name |
stents, drains and dilators for the biliary ducts
|
510(k) Number |
K063733 |
Device Name |
RESOLVE BILIARY DRAINAGE CATHETER |
Applicant |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Applicant Contact |
AMY MCKINNEY |
Correspondent |
MERIT MEDICAL SYSTEMS, INC. |
1600 WEST MERIT PKWY. |
SOUTH JORDAN,
UT
84095
|
|
Correspondent Contact |
AMY MCKINNEY |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 12/18/2006 |
Decision Date | 11/14/2007 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|