| Device Classification Name |
apparatus, suction, patient care
|
|---|
| 510(K) Number |
K121849 |
|---|
| Model |
50-7000B, 50-7280, 50-7260, TBD
|
| Device Name |
PLEURX PLEURAL CATHETER SYSTEM, PLEURX CATHETER ACCESS KIT, PLEURX CATHETER INSERTION STYLET, PLEURX INTEGRAL VALVED PEE |
|---|
| Applicant |
| CAREFUSION |
| 1500 waukegan road |
|
mcgaw park,
IL
60085
|
|
| Contact |
joy greidanus |
| Regulation Number | 870.5050
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/25/2012 |
|---|
| Decision Date | 10/18/2012 |
|---|
| Decision |
substantially equivalent (SE) |
|---|
| Classification Advisory Committee |
Cardiovascular
|
|---|
| Review Advisory Committee |
Anesthesiology
|
|---|
| summary |
summary
|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Expedited Review |
No
|
|---|
| Combination Product |
No
|
|---|
|
|
