EVERCROSS 0.035 OTW PTA DILATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K103322
Device Name EVERCROSS 0.035 OTW PTA DILATION CATHETER
Applicant
EV3 INC
3033 campus drive
plymouth, 
MN 
55441

Applicant Contact david worrell, ms, rac
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 11/12/2010
Decision Date 12/06/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Traditional
Reviewed by Third Party Yes

Combination Product

No

Recalls CDRH Recalls