FOXCROSS PTA CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K081417
Device Name FOXCROSS PTA CATHETER
Applicant
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara, 
CA 
95054

Applicant Contact nadine smith
Correspondent
ABBOTT VASCULAR INC.
3200 lakeside drive
santa clara, 
CA 
95054

Correspodent Contact nadine smith
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 05/20/2008
Decision Date 06/04/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No