VASCUTRAK PTA DILATATION CATHETER


Device Classification Name

catheter, angioplasty, peripheral, transluminal

510(k) Number K103459
Device Name VASCUTRAK PTA DILATATION CATHETER
Applicant
C. R. BARD, INC.
1625 w 3rd street
tempe, 
AZ 
85281

Applicant Contact candace wade
Regulation Number 870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received 11/24/2010
Decision Date 12/13/2010
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No