MODIFICATION TO: FOX PLUS PTA CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K080264
Device Name MODIFICATION TO: FOX PLUS PTA CATHETER
Applicant
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 lakeside dr.
santa clara, 
CA 
95054

Applicant Contact ivalee cohen
Correspondent
ABBOTT VASCULAR-VASCULAR SOLUTIONS
3200 lakeside dr.
santa clara, 
CA 
95054

Correspodent Contact ivalee cohen
Regulation Number 870.1250
Classification Product Code
LIT  
Date Received 02/01/2008
Decision Date 03/26/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No