Device Classification Name |
biliary catheter for stone removal that may also allow for irrigation and contrast injection
|
510(k) Number |
K200247 |
Device Name |
Fusion Quattro Extraction Balloon |
Applicant |
Wilson-Cook Medical, Inc |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Applicant Contact |
Tiffanny A Thomas |
Correspondent |
Wilson-Cook Medical, Inc |
4900 Bethania Station Road |
Winston-Salem,
NC
27105
|
|
Correspondent Contact |
Tiffanny A Thomas |
Regulation Number | 876.5010
|
Classification Product Code |
|
Date Received | 01/31/2020 |
Decision Date | 02/27/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|