GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K081454
Device Name GUARDDOG OCCLUSION GUIDEWIRE, INFLATION DEVICE
Applicant
POSSIS MEDICAL, INC.
9055 evergreen blvd., n.w.
minneapolis, 
MN 
55433 -8003

Applicant Contact mike burnside
Correspondent
POSSIS MEDICAL, INC.
9055 evergreen blvd., n.w.
minneapolis, 
MN 
55433 -8003

Correspodent Contact mike burnside
Regulation Number 870.4450
Classification Product Code
MJN  
Date Received 05/23/2008
Decision Date 06/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No