Device Classification Name |
peritoneal, drainage catheter for refractory ascites, long-term indwelling
|
510(k) Number |
K122422 |
Device Name |
PLEURX PLEURAL CATHETER SYSTEM PLEURX CATHETER ACCESS KIT PLEURX SLIDE VALVED PEELABLE INTRODUCER |
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 | 876.5630
|
Classification Product Code |
|
Date Received | 08/09/2012 |
Decision Date | 10/24/2012 |
Decision |
Substantially Equivalent - Kit
(SESK) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|