EVERCROSS 0.035 OTW PTA DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K110319
Device Name EVERCROSS 0.035 OTW PTA DILATATION CATHETER
Applicant
EV3 INC
3033 campus drive
plymouth, 
MN 
55441

Applicant Contact paula cordero
Correspondent
EV3 INC
3033 campus drive
plymouth, 
MN 
55441

Correspodent Contact paula cordero
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 02/03/2011
Decision Date 04/14/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No