| Device Classification Name |
catheter, peritoneal, long-term indwelling
|
|---|
| 510(K) Number |
K122422 |
|---|
| Models |
50-7280,
50-9000B
|
| Device Name |
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER |
|---|
| Applicant |
| CAREFUSION |
| 1500 waukegan road |
|
mcgaw park \,
IL
60085
|
|
| Contact |
joy greidanus |
| Regulation Number | 876.5630
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 08/09/2012 |
|---|
| Decision Date | 10/24/2012 |
|---|
| Decision |
substantially equivalent - kit (SK) |
|---|
| 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
|
|---|
|
|
