MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES

Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K033264
Device Name MALLEABLE SINGLE STAGE VENOUS CANNULA WITH CARMEDA BIOACTIVE SURFACE, MODEL CB681XX SERIES
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
minneapolis, 
MN 
55038

Applicant Contact preeti jain
Correspondent
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
minneapolis, 
MN 
55038

Correspodent Contact preeti jain
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 10/09/2003
Decision Date 10/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls