PRUITT CAROTID KIT


Device Classification Name

catheter, intravascular occluding, temporary

510(k) Number K103356
Device Name PRUITT CAROTID KIT
Applicant
LEMAITRE VASCULAR, INC.
63 2nd avenue
burlington, 
MA 
01803

Applicant Contact vic zhang
Correspondent
LEMAITRE VASCULAR, INC.
63 2nd avenue
burlington, 
MA 
01803

Correspodent Contact vic zhang
Regulation Number 870.4450
Classification Product Code
MJN  
Subsequent Product Code
FTM  
Date Received 11/16/2010
Decision Date 12/08/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No