SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE

Device Classification Name

catheter, cannula and tubing, vascular, cardiopulmonary bypass

510(k) Number K033416
Device Name SELECT 3D ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE AND SELECT CAP ARTERIAL CANNULA WITH CARMEDA BIOACTIVE SURFACE
Applicant
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
brooklyn park, 
MN 
55428

Applicant Contact ronald w bennett
Correspondent
MEDTRONIC PERFUSION SYSTEMS
7611 northland dr.
brooklyn park, 
MN 
55428

Correspodent Contact ronald w bennett
Regulation Number 870.4210
Classification Product Code
DWF  
Date Received 10/27/2003
Decision Date 11/05/2003
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