Device Classification Name |
Apparatus, Suction, Patient Care
|
510(k) Number |
K121849 |
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
|
|
Applicant Contact |
JOY GREIDANUS |
Correspondent |
CAREFUSION |
1500 WAUKEGAN ROAD |
MCGAW PARK,
IL
60085
|
|
Correspondent Contact |
JOY GREIDANUS |
Regulation Number | 870.5050
|
Classification Product Code |
|
Date Received | 06/25/2012 |
Decision Date | 10/18/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Anesthesiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|