PLEURX PLEURAL CATHETER SYSTEMS


Device Classification Name

apparatus, suction, patient care

510(k) Number K112831
Device Name PLEURX PLEURAL CATHETER SYSTEMS
Applicant
CAREFUSION
1500 waukegan road
waukegan, 
IL 
60085

Applicant Contact joy greidanus
Correspondent
CAREFUSION
1500 waukegan road
waukegan, 
IL 
60085

Correspodent Contact joy greidanus
Regulation Number 870.5050
Classification Product Code
DWM  
Date Received 09/28/2011
Decision Date 02/16/2012
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Anesthesiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No