NOVAPORT ONE VASCULAR ACCESS CANNULA


Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K112565
Device Name NOVAPORT ONE VASCULAR ACCESS CANNULA
Applicant
NOVALUNG GMBH
3550 west liberty rd.
ann arbor, 
MI 
48103

Applicant Contact leann christman
Correspondent
NOVALUNG GMBH
3550 west liberty rd.
ann arbor, 
MI 
48103

Correspodent Contact leann christman
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 09/02/2011
Decision Date 12/06/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No