GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM


Device Classification Name

temporary coronary saphenous vein bypass graft for embolic protection

510(k) Number K023878
Device Name GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM
Original Applicant
MEDTRONIC VASCULAR
37a cherry hill dr.
danvers, 
MA 
01923

Original Contact fred l boucher
Regulation Number 870.1250
Classification Product Code
NFA  
Date Received 11/21/2002
Decision Date 01/24/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No