| Device Classification Name |
catheter, biliary, diagnostic
|
|---|
| 510(K) Number |
K121430 |
|---|
| Models |
EVO-10-11-X-B, WHERE X CAN BE 4,6,8, OR 10,
EVO-8-9-X-B, WHERE X CAN BE 4, 6, 8, OR 10
|
| Device Name |
EVOLUTION BILIARY STENT SYSTEM |
|---|
| Applicant |
| COOK IRELAND LTD |
| o halloran road |
| national technology park |
|
limerick,
|
|
| Contact |
jacinta kilmartin |
| Regulation Number | 876.5010
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 05/14/2012 |
|---|
| Decision Date | 03/01/2013 |
|---|
| Decision |
substantially equivalent - with limitations (SU) |
|---|
| Classification Advisory Committee |
Gastroenterology/Urology
|
|---|
| Review Advisory Committee |
Gastroenterology/Urology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
