GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID


Device Classification Name

temporary carotid catheter for embolic capture

510(k) Number K072990
Device Name GUARDWIRE TEMPORARY OCCLUSION AND ASPIRATION SYSTEM- CAROTID
Applicant
MEDTRONIC INC.
37a cherry hill drive
danvers, 
MA 
01923

Applicant Contact karen a brozowski
Correspondent
MEDTRONIC INC.
37a cherry hill drive
danvers, 
MA 
01923

Correspodent Contact karen a brozowski
Regulation Number 870.1250
Classification Product Code
NTE  
Date Received 10/24/2007
Decision Date 10/31/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No